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New Products/Product News
New Products/Product News
Swede-O has introduced the Thermoskin OL Knee Brace, an offloading knee brace designed for patients who wish to continue activities after injury, after surgery, or with arthritic conditions. Soft-molded condyle pads in this secure contact brace provide joint line contact for exceptional medial and lateral stability. No tools are required to easily change flexion/extension stop adjustments, which add extra protection in controlling range of motion as patients increase their range of activities.
Indications include instabilities of the anterior cruciate and/or posterior cruciate ligaments; instabilities of the medial collateral and/or lateral collateral ligaments; combined instabilities (with or without surgery); osteoarthritis; and degenerative joint disease. The company notes that the brace features a rigid, durable, and lightweight aluminum frame construction and soft condyle pads to enhance stability and patient compliance. The hinge is easy to adjust without tools to save time, and holders on hinge pins minimize lost parts. Straps are numbered for ease of application, and the brace enables activity to promote muscle conditioning. For more information, contact Swede-O |
| Medtronic, Inc., has announced availability of the company’s new Midas Rex® Legend® EHS Stylus Touch™ high-speed electric drill for spinal, cranial, and orthopedic surgical procedures. This is the first electric drill from Medtronic with integrated finger control and is based on the well-established Legend EHS Stylus® motor. With high torque and a compact size, the Legend EHS Stylus Touch drill offers excellent balance and maneuverability for procedures in tight anatomic spaces, according to Medtronic. Surgeons can operate the drill using finger control only, footpedal control, or both. Medtronic notes that the Legend EHS Stylus Touch drill features ergonomic positioning and true variable-speed adjustment, easyto- use design and quick set-up, and adjustable speeds from 200 to 75,000 RPM. The Legend EHS Stylus Touch drill is powered by Medtronic’s Integrated Power Console (IPC®) system, a multispecialty surgical power console that offers improved intraoperative functionality. With the IPC system’s intuitive touchscreen interface, surgeons can use saved custom settings, quickly adjust irrigation via simple remote control, and run multiple Medtronic handpieces. As part of the standardized Legend platform, the Legend EHS Stylus Touch drill works with Medtronic’s interchangeable Legend tools and attachments for a broad range of surgical procedures. To learn more, contact Medtronic |
| Medtronic, Inc., announced the launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. With this product, Medtronic now has a portfolio of cements offering surgeons a choice for treating VCF patients. Surgeons performing KYPHON Balloon Kyphoplasty can now use either KYPHON HV-R® Bone Cement, a PMMA bone cement, or KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a PMMA-HA composite bone cement. HA is chemically and structurally similar to the mineral component of bone, has been widely studied,1 and has a long history of use in dental and orthopedic implants. In a non-human trial* where KYPHON ActivOs 10 Bone Cement with Hydroxyapatite was implanted into 8 rabbit femurs, new bone was seen to form on the surface of the cement without an intervening fibrous tissue layer, and no inflammatory foreign body reaction was observed. This suggests that the surface of the cement is compatible with bone. The complication rate with KYPHON Balloon Kyphoplasty has been demonstrated to be low.2 There are risks associated with the procedure (eg, cement leakage), including serious complications, and, though rare, some of these may be fatal. KYPHON® Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, MD. For more information, contact Medtronic Reference |
| PEAK Surgical, Inc., announced the launch of the PEAK PlasmaBlade® 3.0S dissection device following 510(k) clearance from the US Food and Drug Administration (FDA). The company notes that this product features a 3.0-mm wide blade for greater cutting precision, integrated suction for enhanced visibility, and a telescoping shaft that extends from 5.5 cm to 15 cm for improved surgical access. The PlasmaBlade 3.0S is cleared for use in general; plastic and reconstructive; ear, nose, and throat (ENT); gynecologic; orthopedic; arthroscopic; spinal; and neurologic surgical procedures in the United States. For more information, contact PEAK Surgical |
SCS Lead Splitters
| Boston Scientific Corporation announced US FDA approval and launch of 2 spinal cord stimulation (SCS) lead splitters for use with its Precision Plus™ Spinal Cord Stimulator System, the first rechargeable SCS device for the management of chronic pain of the trunk, back, and/or limbs. The W4 and D4 splitters each enable multisite placement of up to 4 leads, which are designed to deliver electrical pulses to the spinal cord that mask pain signals to the brain. The company notes that the new splitters offer a broader range of lead configurations and are designed to provide physicians more treatment options for their chronic pain patients. For more information, contact Boston Scientific |
| Modern Plastics has added extruded-plate MediPEEK™-IM, a permanent implantable medical- grade PEEK (polyetheretherketone) , to its medical -grade plastics offering. MediPEEK-IM is a high-performance semi-crystalline thermoplastic designed for long-term body contact. The resin is produced to ASTM F2026 specifications and has been extensively tested to ISO-10993 requirements. For more information, contact Modern Plastics |
Swede-O has introduced the Thermoskin OL Knee Brace, an offloading knee brace designed for patients who wish to continue activities after injury, after surgery, or with arthritic conditions. Soft-molded condyle pads in this secure contact brace provide joint line contact for exceptional medial and lateral stability. No tools are required to easily change flexion/extension stop adjustments, which add extra protection in controlling range of motion as patients increase their range of activities.
Indications include instabilities of the anterior cruciate and/or posterior cruciate ligaments; instabilities of the medial collateral and/or lateral collateral ligaments; combined instabilities (with or without surgery); osteoarthritis; and degenerative joint disease. The company notes that the brace features a rigid, durable, and lightweight aluminum frame construction and soft condyle pads to enhance stability and patient compliance. The hinge is easy to adjust without tools to save time, and holders on hinge pins minimize lost parts. Straps are numbered for ease of application, and the brace enables activity to promote muscle conditioning. For more information, contact Swede-O |
| Medtronic, Inc., has announced availability of the company’s new Midas Rex® Legend® EHS Stylus Touch™ high-speed electric drill for spinal, cranial, and orthopedic surgical procedures. This is the first electric drill from Medtronic with integrated finger control and is based on the well-established Legend EHS Stylus® motor. With high torque and a compact size, the Legend EHS Stylus Touch drill offers excellent balance and maneuverability for procedures in tight anatomic spaces, according to Medtronic. Surgeons can operate the drill using finger control only, footpedal control, or both. Medtronic notes that the Legend EHS Stylus Touch drill features ergonomic positioning and true variable-speed adjustment, easyto- use design and quick set-up, and adjustable speeds from 200 to 75,000 RPM. The Legend EHS Stylus Touch drill is powered by Medtronic’s Integrated Power Console (IPC®) system, a multispecialty surgical power console that offers improved intraoperative functionality. With the IPC system’s intuitive touchscreen interface, surgeons can use saved custom settings, quickly adjust irrigation via simple remote control, and run multiple Medtronic handpieces. As part of the standardized Legend platform, the Legend EHS Stylus Touch drill works with Medtronic’s interchangeable Legend tools and attachments for a broad range of surgical procedures. To learn more, contact Medtronic |
| Medtronic, Inc., announced the launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. With this product, Medtronic now has a portfolio of cements offering surgeons a choice for treating VCF patients. Surgeons performing KYPHON Balloon Kyphoplasty can now use either KYPHON HV-R® Bone Cement, a PMMA bone cement, or KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a PMMA-HA composite bone cement. HA is chemically and structurally similar to the mineral component of bone, has been widely studied,1 and has a long history of use in dental and orthopedic implants. In a non-human trial* where KYPHON ActivOs 10 Bone Cement with Hydroxyapatite was implanted into 8 rabbit femurs, new bone was seen to form on the surface of the cement without an intervening fibrous tissue layer, and no inflammatory foreign body reaction was observed. This suggests that the surface of the cement is compatible with bone. The complication rate with KYPHON Balloon Kyphoplasty has been demonstrated to be low.2 There are risks associated with the procedure (eg, cement leakage), including serious complications, and, though rare, some of these may be fatal. KYPHON® Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, MD. For more information, contact Medtronic Reference |
| PEAK Surgical, Inc., announced the launch of the PEAK PlasmaBlade® 3.0S dissection device following 510(k) clearance from the US Food and Drug Administration (FDA). The company notes that this product features a 3.0-mm wide blade for greater cutting precision, integrated suction for enhanced visibility, and a telescoping shaft that extends from 5.5 cm to 15 cm for improved surgical access. The PlasmaBlade 3.0S is cleared for use in general; plastic and reconstructive; ear, nose, and throat (ENT); gynecologic; orthopedic; arthroscopic; spinal; and neurologic surgical procedures in the United States. For more information, contact PEAK Surgical |
SCS Lead Splitters
| Boston Scientific Corporation announced US FDA approval and launch of 2 spinal cord stimulation (SCS) lead splitters for use with its Precision Plus™ Spinal Cord Stimulator System, the first rechargeable SCS device for the management of chronic pain of the trunk, back, and/or limbs. The W4 and D4 splitters each enable multisite placement of up to 4 leads, which are designed to deliver electrical pulses to the spinal cord that mask pain signals to the brain. The company notes that the new splitters offer a broader range of lead configurations and are designed to provide physicians more treatment options for their chronic pain patients. For more information, contact Boston Scientific |
| Modern Plastics has added extruded-plate MediPEEK™-IM, a permanent implantable medical- grade PEEK (polyetheretherketone) , to its medical -grade plastics offering. MediPEEK-IM is a high-performance semi-crystalline thermoplastic designed for long-term body contact. The resin is produced to ASTM F2026 specifications and has been extensively tested to ISO-10993 requirements. For more information, contact Modern Plastics |
Swede-O has introduced the Thermoskin OL Knee Brace, an offloading knee brace designed for patients who wish to continue activities after injury, after surgery, or with arthritic conditions. Soft-molded condyle pads in this secure contact brace provide joint line contact for exceptional medial and lateral stability. No tools are required to easily change flexion/extension stop adjustments, which add extra protection in controlling range of motion as patients increase their range of activities.
Indications include instabilities of the anterior cruciate and/or posterior cruciate ligaments; instabilities of the medial collateral and/or lateral collateral ligaments; combined instabilities (with or without surgery); osteoarthritis; and degenerative joint disease. The company notes that the brace features a rigid, durable, and lightweight aluminum frame construction and soft condyle pads to enhance stability and patient compliance. The hinge is easy to adjust without tools to save time, and holders on hinge pins minimize lost parts. Straps are numbered for ease of application, and the brace enables activity to promote muscle conditioning. For more information, contact Swede-O |
| Medtronic, Inc., has announced availability of the company’s new Midas Rex® Legend® EHS Stylus Touch™ high-speed electric drill for spinal, cranial, and orthopedic surgical procedures. This is the first electric drill from Medtronic with integrated finger control and is based on the well-established Legend EHS Stylus® motor. With high torque and a compact size, the Legend EHS Stylus Touch drill offers excellent balance and maneuverability for procedures in tight anatomic spaces, according to Medtronic. Surgeons can operate the drill using finger control only, footpedal control, or both. Medtronic notes that the Legend EHS Stylus Touch drill features ergonomic positioning and true variable-speed adjustment, easyto- use design and quick set-up, and adjustable speeds from 200 to 75,000 RPM. The Legend EHS Stylus Touch drill is powered by Medtronic’s Integrated Power Console (IPC®) system, a multispecialty surgical power console that offers improved intraoperative functionality. With the IPC system’s intuitive touchscreen interface, surgeons can use saved custom settings, quickly adjust irrigation via simple remote control, and run multiple Medtronic handpieces. As part of the standardized Legend platform, the Legend EHS Stylus Touch drill works with Medtronic’s interchangeable Legend tools and attachments for a broad range of surgical procedures. To learn more, contact Medtronic |
| Medtronic, Inc., announced the launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. With this product, Medtronic now has a portfolio of cements offering surgeons a choice for treating VCF patients. Surgeons performing KYPHON Balloon Kyphoplasty can now use either KYPHON HV-R® Bone Cement, a PMMA bone cement, or KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a PMMA-HA composite bone cement. HA is chemically and structurally similar to the mineral component of bone, has been widely studied,1 and has a long history of use in dental and orthopedic implants. In a non-human trial* where KYPHON ActivOs 10 Bone Cement with Hydroxyapatite was implanted into 8 rabbit femurs, new bone was seen to form on the surface of the cement without an intervening fibrous tissue layer, and no inflammatory foreign body reaction was observed. This suggests that the surface of the cement is compatible with bone. The complication rate with KYPHON Balloon Kyphoplasty has been demonstrated to be low.2 There are risks associated with the procedure (eg, cement leakage), including serious complications, and, though rare, some of these may be fatal. KYPHON® Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, MD. For more information, contact Medtronic Reference |
| PEAK Surgical, Inc., announced the launch of the PEAK PlasmaBlade® 3.0S dissection device following 510(k) clearance from the US Food and Drug Administration (FDA). The company notes that this product features a 3.0-mm wide blade for greater cutting precision, integrated suction for enhanced visibility, and a telescoping shaft that extends from 5.5 cm to 15 cm for improved surgical access. The PlasmaBlade 3.0S is cleared for use in general; plastic and reconstructive; ear, nose, and throat (ENT); gynecologic; orthopedic; arthroscopic; spinal; and neurologic surgical procedures in the United States. For more information, contact PEAK Surgical |
SCS Lead Splitters
| Boston Scientific Corporation announced US FDA approval and launch of 2 spinal cord stimulation (SCS) lead splitters for use with its Precision Plus™ Spinal Cord Stimulator System, the first rechargeable SCS device for the management of chronic pain of the trunk, back, and/or limbs. The W4 and D4 splitters each enable multisite placement of up to 4 leads, which are designed to deliver electrical pulses to the spinal cord that mask pain signals to the brain. The company notes that the new splitters offer a broader range of lead configurations and are designed to provide physicians more treatment options for their chronic pain patients. For more information, contact Boston Scientific |
| Modern Plastics has added extruded-plate MediPEEK™-IM, a permanent implantable medical- grade PEEK (polyetheretherketone) , to its medical -grade plastics offering. MediPEEK-IM is a high-performance semi-crystalline thermoplastic designed for long-term body contact. The resin is produced to ASTM F2026 specifications and has been extensively tested to ISO-10993 requirements. For more information, contact Modern Plastics |
New Products/Product News
Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System.
The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States.
Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties.
The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network.
For more information, contact
|
Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction.
KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee.
The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
For more information, contact
KFx Medical Corporation
|
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results.
With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur.
Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand.
The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force.
For more information, contact
Wright Medical Technology
|
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants.
The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options.
In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.
For more information, contact
Amedica
|
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months.
Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1
The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo.
ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.
To review the Prolia prescribing information and REMS materials, visit www.amgen.com.
For more information, contact
References
Amgen Inc.
|
Disposable Biter
OrthoDynamix has introduced the ArthroSteer Biter. It is the first disposable biter used for meniscal shoulder and knee repair. A sharp jaw for every procedure affords excellent tissue interaction. Moreover, the Biter is steerable, allowing access to and around joint capsule structures. Besides the jaw’s ability to bend 180°, the jaw orientation to the tissue plane is made possible by the 360° jaw rotation, which is independent of the bend. OrthoDynamix notes that the ArthroSteer Biter can eliminate dozens of reusable biter instruments configured with varying preset bent shafts.
OrthoDynamix is a Gyrx LLC portfolio company.
To learn more, contact
OrthoDynamix
|
Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System.
The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States.
Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties.
The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network.
For more information, contact
|
Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction.
KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee.
The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
For more information, contact
KFx Medical Corporation
|
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results.
With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur.
Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand.
The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force.
For more information, contact
Wright Medical Technology
|
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants.
The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options.
In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.
For more information, contact
Amedica
|
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months.
Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1
The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo.
ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.
To review the Prolia prescribing information and REMS materials, visit www.amgen.com.
For more information, contact
References
Amgen Inc.
|
Disposable Biter
OrthoDynamix has introduced the ArthroSteer Biter. It is the first disposable biter used for meniscal shoulder and knee repair. A sharp jaw for every procedure affords excellent tissue interaction. Moreover, the Biter is steerable, allowing access to and around joint capsule structures. Besides the jaw’s ability to bend 180°, the jaw orientation to the tissue plane is made possible by the 360° jaw rotation, which is independent of the bend. OrthoDynamix notes that the ArthroSteer Biter can eliminate dozens of reusable biter instruments configured with varying preset bent shafts.
OrthoDynamix is a Gyrx LLC portfolio company.
To learn more, contact
OrthoDynamix
|
Aesculap Implant Systems, LLC, has announced the launch of the S4 Element Pedicle Screw System.
The S4 Element Pedicle Screw System was made available to a select group of surgeons in May 2009 as part of the company’s Market Preference Evaluation, and a full launch of the system is planned for the second quarter of 2010, at which time the system will be released to surgeons throughout the United States.
Aesculap notes that some of S4 Element’s unique features include an industry-leading ultra-low-profile screw head for minimal impingement of anatomical structures and innovative placement instruments, like the speed-multiplier handle, which facilitates tapping and screw placement at a 3.5 times faster rate without altering bone–screw thread properties.
The S4 Element System will be sold through the Aesculap Implant Systems direct and indirect sales network.
For more information, contact
|
Soft-Tissue Repair
KFx Medical Corporation announced it has received 510k clearance from the US Food and Drug Administration (FDA) for products used in a wide variety of arthroscopic tenodesis knee procedures, such as anterior cruciate ligament, posterior cruciate ligament, and medial patellofemoral ligament reconstruction.
KFx Medical has also received 510k clearance from the FDA for its AppianFx™ product line for soft-tissue repair and reconstruction in the knee.
The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot, and ankle procedures, which, combined, exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
For more information, contact
KFx Medical Corporation
|
Hindfoot Deformities and Arthritis Treatment
Wright Medical Group, Inc., has announced the full commercial launch of the VALOR® Hindfoot Fusion Nail. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial premarket availability announced in November 2009, the system has been limited to use in a few centers in the United States, gathering early clinical results.
With an array of sizes and anatomical screw positions, the VALOR® Nail is designed to provide optimal fixation for each patient’s unique anatomy and condition. Each fusion nail also incorporates an internal compression device that allows the surgeon to control the compression between bone surfaces, thereby optimizing the conditions for fusion to occur.
Wright estimates that over 30,000 hindfoot fusion procedures are performed annually in the United States, and over 50% are estimated to be treated with a fusion nail. With the expanding diabetic population, the number of patients requiring a nail option for salvage will continue to expand.
The new VALOR® Hindfoot Fusion system will be made available immediately through Wright’s specialized Foot and Ankle sales force.
For more information, contact
Wright Medical Technology
|
Monoblock Ceramic Technology
Amedica Corporation, a spinal and orthopedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has been granted a US patent covering its novel hip implant featuring a monoblock ceramic acetabular cup for use in articulating joints for total joint replacement. Currently under development, Amedica’s cup covered under this and other pending patents will be used as an ultra–low–wear–bearing component for motion-preserving implants.
The technology allows Amedica to combine high-strength silicon nitride ceramic with an ultra–low–wear surface–bearing technology, along with a bone-contacting Bioactive™ surface designed for secure, long-term fixation. Amedica notes that this provides surgeons with wider design choices and flexibility to improve anatomic fit and function compared with currently available alternate bearing options.
In addition to spinal implants, Amedica’s SiN materials have disruptive characteristics for hip and knee implant applications as well. The material is fracture-resistant; its articulating surfaces do not produce the wear debris that is linked to osteolysis-related reoperations. Additionally, the company notes that the Bioactive implants feature a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.
For more information, contact
Amedica
|
Postmenopausal Osteoporosis Treatment
Amgen, Inc., announced that the US FDA has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or of patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is a 60-mg subcutaneous injection administered by a health care professional every 6 months.
Prolia’s approval is based on a pivotal 3-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip, and nonvertebral fractures measured at 3 years.1
The pivotal 3-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that treatment with Prolia, administered as a 60-mg subcutaneous injection every 6 months, compared with placebo at 3 years resulted in: a 68% reduction in vertebral fractures (4.8% absolute risk reduction), a 40% reduction in hip fractures (0.3% absolute risk reduction), a 20% reduction in nonvertebral fractures (1.5% absolute risk reduction), and significant bone density increases at all key sites measured (8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck).2 The incidence of new spine fractures was 2.3% with Prolia vs. 7.2% with placebo. The incidence of hip fractures was 0.7% with Prolia vs. 1.2% with placebo. The incidence of non-spine fractures was 6.5% with Prolia vs. 8% with placebo.
ProliaPlus™ is a multifaceted product support program designed to provide comprehensive assistance to health care providers, patients, and their caregivers to help facilitate access to Prolia for appropriate patients. ProliaPlus provides information and assistance on issues related to product insurance coverage to physician offices. Additionally, upon request, ProliaPlus will remind patients and providers about when the patient’s next dose is due, thus helping to support patient adherence to therapy. ProliaPlus will also have information on the availability of potential financial assistance programs.
To review the Prolia prescribing information and REMS materials, visit www.amgen.com.
For more information, contact
References
Amgen Inc.
|
Disposable Biter
OrthoDynamix has introduced the ArthroSteer Biter. It is the first disposable biter used for meniscal shoulder and knee repair. A sharp jaw for every procedure affords excellent tissue interaction. Moreover, the Biter is steerable, allowing access to and around joint capsule structures. Besides the jaw’s ability to bend 180°, the jaw orientation to the tissue plane is made possible by the 360° jaw rotation, which is independent of the bend. OrthoDynamix notes that the ArthroSteer Biter can eliminate dozens of reusable biter instruments configured with varying preset bent shafts.
OrthoDynamix is a Gyrx LLC portfolio company.
To learn more, contact
OrthoDynamix
|
New Products/Product News
OA, RA, and Ankylosing Spondylitis Treatment Option
| AstraZeneca and POZEN, Inc., announced that the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN, Inc., and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared with patients receiving enteric-coated naproxen. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers. In the PN400-301 and -302 studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO compared with 23.1% among patients taking enteric-coated naproxen (P<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO compared with 24.3% with enteric-coated naproxen (P<0.001). The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea. For more information, contact
|
Soft-Tissue Coagulation Device
| Bovie Medical Corporation has announced that they have received clearance from the US Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology. For more information, contact Bovie Medical |
Demineralized Bone Matrix
| Aesculap Implant Systems, LLC, has announced the launch of the new ProSpace DBM-D, a demineralized bone matrix available in two forms—a “flowable” paste or “moldable” putty. The moldable putty contains cortical-cancellous chips that create a 3-D scaffold for optimized osteoconduction. ProSpace DBM-D pastes and putties serve as bone void filler in many surgical applications. Unique features associated with this product allow for room temperature storage and re-hydration with a choice of fluids, including a patient’s own blood, sterile water, or saline. ProSpace DBM-D is manufactured for Aesculap by RTI Biologics, Inc. For more information, contact Aesculap |
Orthopedic Trauma Launch
| Salient Surgical Technologies, Inc., announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures. Already in wide use for spinal fusion and orthopedic reconstruction of the hip and knee, the AQUAMANTYS System can help surgeons achieve hemostasis quickly while avoiding damage to delicate structures. Typical applications include lower-limb amputation, pelvic osteotomy, and large débridement procedures; sacral, hip, periprosthetic and femoral fractures; and long-bone nonunion procedures. The AQUAMANTYS System employs TRANSCOLLATION™ technology, Salient’s proprietary combination of radiofrequency energy and saline that seals specific types of collagen-based tissues while maintaining temperatures at or below 100°C. TRANSCOLLATION technology allows surgeons to rapidly treat tissue at the surgical site by transforming specific types of collagen-based structures to improve patient outcomes. To learn more, contact Salient |
30-Year Knee
| Smith & Nephew Orthopaedics Division has announced the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company’s LEGION◊ knee replacement, VERILAST technology produced an 81% reduction* in wear, the leading cause of knee replacement failure. The FDA has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology’s ability to “provide wear performance sufficient for 30 years of actual use under typical conditions.” The consensus of scientific literature is that knee implants are expected to last 10 to 15 years. VERILAST technology is the combination of 2 advanced bearing surface technologies: Smith & Nephew’s patented metal alloy OXINIUM oxidized zirconium, used on the femoral side of the joint, and highly cross-linked polyethylene (plastic), implanted on the tibial side. OXINIUM◊ material has been in use in knee replacements for more than a decade, but was only recently coupled with highly cross-linked polyethylene components. OXINIUM is a metal alloy that undergoes a heating process, transforming its surface into a hard, smooth ceramic that is 4,900 times more resistant to scratching than traditional materials. Smith & Nephew notes that OXINIUM is 20% lighter than cobalt chromium, the metal used in conventional knee replacements, and because it doesn’t contain detectable amounts of nickel like cobalt chromium does, it is considered hypoallergenic and safe for patients with metal allergies. Smith & Nephew’s primary knee replacement systems, the LEGION◊ and GENESIS◊ II knee implants, are currently available with VERILAST technology. For more information, contact *As compared with wear simulator data seen for a traditional bearing couple for an estimated 5 years. Smith & Nephew, Inc. |
CMC Implant
| Ascension Orthopedics, Inc., has announced the launch of the Ascension® NuGripTM CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. The company notes that the implant is a bone-preserving, reliable alternative to soft-tissue reconstruction, which is the standard treatment for this indication. The Ascension NuGrip CMC implant is a single component that minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium. The device offers 8 sizing options to fit patient anatomy. To learn more, contact Ascension Orthopedics |
OA, RA, and Ankylosing Spondylitis Treatment Option
| AstraZeneca and POZEN, Inc., announced that the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN, Inc., and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared with patients receiving enteric-coated naproxen. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers. In the PN400-301 and -302 studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO compared with 23.1% among patients taking enteric-coated naproxen (P<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO compared with 24.3% with enteric-coated naproxen (P<0.001). The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea. For more information, contact
|
Soft-Tissue Coagulation Device
| Bovie Medical Corporation has announced that they have received clearance from the US Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology. For more information, contact Bovie Medical |
Demineralized Bone Matrix
| Aesculap Implant Systems, LLC, has announced the launch of the new ProSpace DBM-D, a demineralized bone matrix available in two forms—a “flowable” paste or “moldable” putty. The moldable putty contains cortical-cancellous chips that create a 3-D scaffold for optimized osteoconduction. ProSpace DBM-D pastes and putties serve as bone void filler in many surgical applications. Unique features associated with this product allow for room temperature storage and re-hydration with a choice of fluids, including a patient’s own blood, sterile water, or saline. ProSpace DBM-D is manufactured for Aesculap by RTI Biologics, Inc. For more information, contact Aesculap |
Orthopedic Trauma Launch
| Salient Surgical Technologies, Inc., announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures. Already in wide use for spinal fusion and orthopedic reconstruction of the hip and knee, the AQUAMANTYS System can help surgeons achieve hemostasis quickly while avoiding damage to delicate structures. Typical applications include lower-limb amputation, pelvic osteotomy, and large débridement procedures; sacral, hip, periprosthetic and femoral fractures; and long-bone nonunion procedures. The AQUAMANTYS System employs TRANSCOLLATION™ technology, Salient’s proprietary combination of radiofrequency energy and saline that seals specific types of collagen-based tissues while maintaining temperatures at or below 100°C. TRANSCOLLATION technology allows surgeons to rapidly treat tissue at the surgical site by transforming specific types of collagen-based structures to improve patient outcomes. To learn more, contact Salient |
30-Year Knee
| Smith & Nephew Orthopaedics Division has announced the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company’s LEGION◊ knee replacement, VERILAST technology produced an 81% reduction* in wear, the leading cause of knee replacement failure. The FDA has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology’s ability to “provide wear performance sufficient for 30 years of actual use under typical conditions.” The consensus of scientific literature is that knee implants are expected to last 10 to 15 years. VERILAST technology is the combination of 2 advanced bearing surface technologies: Smith & Nephew’s patented metal alloy OXINIUM oxidized zirconium, used on the femoral side of the joint, and highly cross-linked polyethylene (plastic), implanted on the tibial side. OXINIUM◊ material has been in use in knee replacements for more than a decade, but was only recently coupled with highly cross-linked polyethylene components. OXINIUM is a metal alloy that undergoes a heating process, transforming its surface into a hard, smooth ceramic that is 4,900 times more resistant to scratching than traditional materials. Smith & Nephew notes that OXINIUM is 20% lighter than cobalt chromium, the metal used in conventional knee replacements, and because it doesn’t contain detectable amounts of nickel like cobalt chromium does, it is considered hypoallergenic and safe for patients with metal allergies. Smith & Nephew’s primary knee replacement systems, the LEGION◊ and GENESIS◊ II knee implants, are currently available with VERILAST technology. For more information, contact *As compared with wear simulator data seen for a traditional bearing couple for an estimated 5 years. Smith & Nephew, Inc. |
CMC Implant
| Ascension Orthopedics, Inc., has announced the launch of the Ascension® NuGripTM CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. The company notes that the implant is a bone-preserving, reliable alternative to soft-tissue reconstruction, which is the standard treatment for this indication. The Ascension NuGrip CMC implant is a single component that minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium. The device offers 8 sizing options to fit patient anatomy. To learn more, contact Ascension Orthopedics |
OA, RA, and Ankylosing Spondylitis Treatment Option
| AstraZeneca and POZEN, Inc., announced that the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN, Inc., and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared with patients receiving enteric-coated naproxen. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of developing gastrointestinal ulcers. In the PN400-301 and -302 studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO compared with 23.1% among patients taking enteric-coated naproxen (P<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO compared with 24.3% with enteric-coated naproxen (P<0.001). The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea. For more information, contact
|
Soft-Tissue Coagulation Device
| Bovie Medical Corporation has announced that they have received clearance from the US Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology. For more information, contact Bovie Medical |
Demineralized Bone Matrix
| Aesculap Implant Systems, LLC, has announced the launch of the new ProSpace DBM-D, a demineralized bone matrix available in two forms—a “flowable” paste or “moldable” putty. The moldable putty contains cortical-cancellous chips that create a 3-D scaffold for optimized osteoconduction. ProSpace DBM-D pastes and putties serve as bone void filler in many surgical applications. Unique features associated with this product allow for room temperature storage and re-hydration with a choice of fluids, including a patient’s own blood, sterile water, or saline. ProSpace DBM-D is manufactured for Aesculap by RTI Biologics, Inc. For more information, contact Aesculap |
Orthopedic Trauma Launch
| Salient Surgical Technologies, Inc., announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures. Already in wide use for spinal fusion and orthopedic reconstruction of the hip and knee, the AQUAMANTYS System can help surgeons achieve hemostasis quickly while avoiding damage to delicate structures. Typical applications include lower-limb amputation, pelvic osteotomy, and large débridement procedures; sacral, hip, periprosthetic and femoral fractures; and long-bone nonunion procedures. The AQUAMANTYS System employs TRANSCOLLATION™ technology, Salient’s proprietary combination of radiofrequency energy and saline that seals specific types of collagen-based tissues while maintaining temperatures at or below 100°C. TRANSCOLLATION technology allows surgeons to rapidly treat tissue at the surgical site by transforming specific types of collagen-based structures to improve patient outcomes. To learn more, contact Salient |
30-Year Knee
| Smith & Nephew Orthopaedics Division has announced the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company’s LEGION◊ knee replacement, VERILAST technology produced an 81% reduction* in wear, the leading cause of knee replacement failure. The FDA has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology’s ability to “provide wear performance sufficient for 30 years of actual use under typical conditions.” The consensus of scientific literature is that knee implants are expected to last 10 to 15 years. VERILAST technology is the combination of 2 advanced bearing surface technologies: Smith & Nephew’s patented metal alloy OXINIUM oxidized zirconium, used on the femoral side of the joint, and highly cross-linked polyethylene (plastic), implanted on the tibial side. OXINIUM◊ material has been in use in knee replacements for more than a decade, but was only recently coupled with highly cross-linked polyethylene components. OXINIUM is a metal alloy that undergoes a heating process, transforming its surface into a hard, smooth ceramic that is 4,900 times more resistant to scratching than traditional materials. Smith & Nephew notes that OXINIUM is 20% lighter than cobalt chromium, the metal used in conventional knee replacements, and because it doesn’t contain detectable amounts of nickel like cobalt chromium does, it is considered hypoallergenic and safe for patients with metal allergies. Smith & Nephew’s primary knee replacement systems, the LEGION◊ and GENESIS◊ II knee implants, are currently available with VERILAST technology. For more information, contact *As compared with wear simulator data seen for a traditional bearing couple for an estimated 5 years. Smith & Nephew, Inc. |
CMC Implant
| Ascension Orthopedics, Inc., has announced the launch of the Ascension® NuGripTM CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. The company notes that the implant is a bone-preserving, reliable alternative to soft-tissue reconstruction, which is the standard treatment for this indication. The Ascension NuGrip CMC implant is a single component that minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium. The device offers 8 sizing options to fit patient anatomy. To learn more, contact Ascension Orthopedics |
New Products/Product News
CareFusion announced the launch of the AVAmax® Vertebral Balloon, a minimally invasive device for use during kyphoplasty. CareFusion will offer the new AVAmax Vertebral Balloon as part of a system that includes needles, bone cement, and delivery instruments for both kyphoplasty and vertebroplasty, giving surgeons the choice and flexibility to perform either procedure.
The company notes that the AVAmax Vertebral Balloon and the components needed to perform the procedure will be very competitively priced, making the procedure even more accessible for clinicians and their patients. In addition, the AVAmax® PLUS vertebral augmentation system, used with the AVAmax Vertebral Balloon to deliver cement, has features that allow the radiologist’s hands to be out of the radiation field, making the procedure safer for the clinician.
For more information, contact
CareFusion
|
New Arthroplasty
DePuy Orthopaedics, Inc., has announced the launch of 3 new products. The Delta XTEND™ High Mobility Humeral Cup with Premieron™ X-Linked Polyethylene is a total, semi-constrained shoulder arthroplasty that reverses the normal relationship between the scapular and humeral components. Laboratory testing has shown that the new polyethylene developed for this cup reduces wear debris by 85% over conventionally manufactured and sterilized polyethylene components.1 In addition, the cup has a shallower depth than other cups offered with the system, which may further reduce the risk of scapular neck erosion (notching) while maximizing range of motion for certain patients.
The Global CAP™ CTA, the company’s first resurfacing prosthesis, is indicated for cuff tear arthropathy. In addition to the features and design benefits offered with Global CAP for osteoarthritis or rheumatoid arthritis, Global CAP CTA has an increased area of superolateral articulation and implant geometry designed to compensate for superior humeral head migration to help restore joint stability and range of motion.
Additions to the Anatomic Locked Plating Systems (A.L.P.S.) include an Elbow Plating System designed to allow surgeons to effectively address fractures around the elbow as well as a Proximal Tibia System to addresses a variety of common proximal tibia fractures.
For more information, contact
DePuy Orthopaedics, Inc.
Reference
|
Plating Systems
Stryker Corporation’s Orthopaedics Division announced the release of 3 new plating systems: the VariAx Elbow Locking Plate System, the VariAx Fibula Locking Plate System, and the AxSOS Extremity Plating System, which are all designed to expand the range of treatment options for bone fracture repair.
With use of predetermined screw angulation options for plating systems used in bone fracture repair, the implants may not in some instances have been anatomic or precontoured for the patient’s indication and may not have provided the choice of locking or nonlocking screws. The new AxSOS and VariAx locking plate systems are designed to provide next-generation solutions to these challenges by providing a variety of precontoured plates and straight plates. VariAx also gives surgeons the flexibility to choose the angulation of locking screws.
Stryker notes that the new VariAx Locked Plating Systems feature options that allow surgeons to provide a more customized solution through a wider range of real-time choices in the operating room. Stryker’s AxSOS Extremity Plating System features locking fixation where the surgeon needs it, allowing for greater confidence in fracture fixation and better patient fit.
By using these plating solutions with Stryker’s Asnis Micro Cannulated Screw system, surgeons have multiple plating solutions for bone fractures of the hand, distal radius, elbow, foot, and fibula.
To learn more, contact
Stryker Orthopedics
|
Computer-Assisted TKA System
OrthAlign, Inc., has received 510(k) market clearance from the US Food and Drug Administration for the latest design of its palm-sized disposable KneeAlign™ computer-assisted system for total knee arthroplasty.
For more information, contact
OrthAlign, Inc
|
CareFusion announced the launch of the AVAmax® Vertebral Balloon, a minimally invasive device for use during kyphoplasty. CareFusion will offer the new AVAmax Vertebral Balloon as part of a system that includes needles, bone cement, and delivery instruments for both kyphoplasty and vertebroplasty, giving surgeons the choice and flexibility to perform either procedure.
The company notes that the AVAmax Vertebral Balloon and the components needed to perform the procedure will be very competitively priced, making the procedure even more accessible for clinicians and their patients. In addition, the AVAmax® PLUS vertebral augmentation system, used with the AVAmax Vertebral Balloon to deliver cement, has features that allow the radiologist’s hands to be out of the radiation field, making the procedure safer for the clinician.
For more information, contact
CareFusion
|
New Arthroplasty
DePuy Orthopaedics, Inc., has announced the launch of 3 new products. The Delta XTEND™ High Mobility Humeral Cup with Premieron™ X-Linked Polyethylene is a total, semi-constrained shoulder arthroplasty that reverses the normal relationship between the scapular and humeral components. Laboratory testing has shown that the new polyethylene developed for this cup reduces wear debris by 85% over conventionally manufactured and sterilized polyethylene components.1 In addition, the cup has a shallower depth than other cups offered with the system, which may further reduce the risk of scapular neck erosion (notching) while maximizing range of motion for certain patients.
The Global CAP™ CTA, the company’s first resurfacing prosthesis, is indicated for cuff tear arthropathy. In addition to the features and design benefits offered with Global CAP for osteoarthritis or rheumatoid arthritis, Global CAP CTA has an increased area of superolateral articulation and implant geometry designed to compensate for superior humeral head migration to help restore joint stability and range of motion.
Additions to the Anatomic Locked Plating Systems (A.L.P.S.) include an Elbow Plating System designed to allow surgeons to effectively address fractures around the elbow as well as a Proximal Tibia System to addresses a variety of common proximal tibia fractures.
For more information, contact
DePuy Orthopaedics, Inc.
Reference
|
Plating Systems
Stryker Corporation’s Orthopaedics Division announced the release of 3 new plating systems: the VariAx Elbow Locking Plate System, the VariAx Fibula Locking Plate System, and the AxSOS Extremity Plating System, which are all designed to expand the range of treatment options for bone fracture repair.
With use of predetermined screw angulation options for plating systems used in bone fracture repair, the implants may not in some instances have been anatomic or precontoured for the patient’s indication and may not have provided the choice of locking or nonlocking screws. The new AxSOS and VariAx locking plate systems are designed to provide next-generation solutions to these challenges by providing a variety of precontoured plates and straight plates. VariAx also gives surgeons the flexibility to choose the angulation of locking screws.
Stryker notes that the new VariAx Locked Plating Systems feature options that allow surgeons to provide a more customized solution through a wider range of real-time choices in the operating room. Stryker’s AxSOS Extremity Plating System features locking fixation where the surgeon needs it, allowing for greater confidence in fracture fixation and better patient fit.
By using these plating solutions with Stryker’s Asnis Micro Cannulated Screw system, surgeons have multiple plating solutions for bone fractures of the hand, distal radius, elbow, foot, and fibula.
To learn more, contact
Stryker Orthopedics
|
Computer-Assisted TKA System
OrthAlign, Inc., has received 510(k) market clearance from the US Food and Drug Administration for the latest design of its palm-sized disposable KneeAlign™ computer-assisted system for total knee arthroplasty.
For more information, contact
OrthAlign, Inc
|
CareFusion announced the launch of the AVAmax® Vertebral Balloon, a minimally invasive device for use during kyphoplasty. CareFusion will offer the new AVAmax Vertebral Balloon as part of a system that includes needles, bone cement, and delivery instruments for both kyphoplasty and vertebroplasty, giving surgeons the choice and flexibility to perform either procedure.
The company notes that the AVAmax Vertebral Balloon and the components needed to perform the procedure will be very competitively priced, making the procedure even more accessible for clinicians and their patients. In addition, the AVAmax® PLUS vertebral augmentation system, used with the AVAmax Vertebral Balloon to deliver cement, has features that allow the radiologist’s hands to be out of the radiation field, making the procedure safer for the clinician.
For more information, contact
CareFusion
|
New Arthroplasty
DePuy Orthopaedics, Inc., has announced the launch of 3 new products. The Delta XTEND™ High Mobility Humeral Cup with Premieron™ X-Linked Polyethylene is a total, semi-constrained shoulder arthroplasty that reverses the normal relationship between the scapular and humeral components. Laboratory testing has shown that the new polyethylene developed for this cup reduces wear debris by 85% over conventionally manufactured and sterilized polyethylene components.1 In addition, the cup has a shallower depth than other cups offered with the system, which may further reduce the risk of scapular neck erosion (notching) while maximizing range of motion for certain patients.
The Global CAP™ CTA, the company’s first resurfacing prosthesis, is indicated for cuff tear arthropathy. In addition to the features and design benefits offered with Global CAP for osteoarthritis or rheumatoid arthritis, Global CAP CTA has an increased area of superolateral articulation and implant geometry designed to compensate for superior humeral head migration to help restore joint stability and range of motion.
Additions to the Anatomic Locked Plating Systems (A.L.P.S.) include an Elbow Plating System designed to allow surgeons to effectively address fractures around the elbow as well as a Proximal Tibia System to addresses a variety of common proximal tibia fractures.
For more information, contact
DePuy Orthopaedics, Inc.
Reference
|
Plating Systems
Stryker Corporation’s Orthopaedics Division announced the release of 3 new plating systems: the VariAx Elbow Locking Plate System, the VariAx Fibula Locking Plate System, and the AxSOS Extremity Plating System, which are all designed to expand the range of treatment options for bone fracture repair.
With use of predetermined screw angulation options for plating systems used in bone fracture repair, the implants may not in some instances have been anatomic or precontoured for the patient’s indication and may not have provided the choice of locking or nonlocking screws. The new AxSOS and VariAx locking plate systems are designed to provide next-generation solutions to these challenges by providing a variety of precontoured plates and straight plates. VariAx also gives surgeons the flexibility to choose the angulation of locking screws.
Stryker notes that the new VariAx Locked Plating Systems feature options that allow surgeons to provide a more customized solution through a wider range of real-time choices in the operating room. Stryker’s AxSOS Extremity Plating System features locking fixation where the surgeon needs it, allowing for greater confidence in fracture fixation and better patient fit.
By using these plating solutions with Stryker’s Asnis Micro Cannulated Screw system, surgeons have multiple plating solutions for bone fractures of the hand, distal radius, elbow, foot, and fibula.
To learn more, contact
Stryker Orthopedics
|
Computer-Assisted TKA System
OrthAlign, Inc., has received 510(k) market clearance from the US Food and Drug Administration for the latest design of its palm-sized disposable KneeAlign™ computer-assisted system for total knee arthroplasty.
For more information, contact
OrthAlign, Inc
|
New Products/Product News
The Ortho-Light™ surgical illuminator is a new illumination solution from Lumitex MD® that helps orthopedic surgeons improve visualization in small-incision hip, shoulder, or knee surgeries.
A cool, flexible acrylic fiber optic panel that adheres to retractors, Ortho-Light dramatically improves the view of the surgical cavity with bright, shadowless, continuous area light.
“This light attaches to any retractor and provides superb visualization during preparation of the acetabulum for total hip replacement, no matter the incision,” commented Dr. Larry Dorr of the Dorr Arthritis Institute. “It improves safety of the operation and eliminates the need for the surgeon to wear a headlight, which improves surgical field of vision.”
The patented disposable, single-use-only device is sterile and latex-free, and is designed to be safe, simple, and economical to use. Ortho-Light is flexible and low-profile; attaches easily to virtually any retractor using a biocompatible, two-sided adhesive; and inserts directly into the surgical cavity.
For more information, contact
LumitexMD®, Inc
|
Extremity Medical, LLC, announced that it has received FDA clearance for the TrapEZX™ Anatomic Trapezium Prosthesis. The company also announced that it had received CE Mark for the product and is initiating limited release in selected centers in the United States and Europe. Extremity Medical notes that the TrapEZX Prosthesis is the first completely anatomic trapezium bone replacement available in the world.
The device is intended to treat degenerative and posttraumatic disabilities of the thumb basal joint. The TrapEZX Trapezium Replacement is the first of its kind that is anatomic and incorporates a window designed to offer the potential of hematoma encapsulation for long term stability.
For more information, contact
Extremity Medical, LLC
|
Morphine Sulfate Oral Solution
Roxane Laboratories, Inc., announced the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution Cll, 100 mg per 5 mL (20 mg/mL), 30 mL, and 120 mL bottles by the US Food and Drug Administration (FDA). This product is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
Roxane Laboratories’ Morphine Sulfate Oral Solution Cll, 100 mg per 5 mL (20 mg/mL) is the only FDA-approved Morphine Sulfate Oral Solution Cll available at this concentration. Full prescribing information for Morphine Sulfate Oral Solution Cll is available on the Roxane Laboratories website.
To learn more, contact
Roxane Laboratories, Inc. - Technical Product Information
|
New Instruments
Integra LifeSciences has introduced 4 new products. Secure-Cut™ Reposable Endoscopic Scissors are composed of a cost-effective reusable carbon fiber handle with a PEEK shaft and “always sharp” single-use scissor tips. The system includes a secure connection composed of stainless steel threading that ensures a robust, lasting connection and a protective PEEK insulation that prevents arcing.
The Ruggles™ Bayonet Curettes allow spine surgeons to see the operative field more clearly by providing an offset handle. The new line of Ruggles Curettes complements Integra’s array of neuro/spine instruments.
The Jarit® Disposable Bi-polar Forceps deliver gentle coagulation between highly polished instrument tips to minimize coagulum adhesion. This important addition to Integra’s forceps portfolio complements its Buzz™ reusable non-stick forceps.
Integra’s improved LumbarTrak™ Retractor System incorporates enhancements to the frame that provide unparalleled strength. The system is designed to help surgeons establish prompt and lasting exposure during their lumbar spine procedures.
For more information, contact
Integra Life Sciences
|
The Ortho-Light™ surgical illuminator is a new illumination solution from Lumitex MD® that helps orthopedic surgeons improve visualization in small-incision hip, shoulder, or knee surgeries.
A cool, flexible acrylic fiber optic panel that adheres to retractors, Ortho-Light dramatically improves the view of the surgical cavity with bright, shadowless, continuous area light.
“This light attaches to any retractor and provides superb visualization during preparation of the acetabulum for total hip replacement, no matter the incision,” commented Dr. Larry Dorr of the Dorr Arthritis Institute. “It improves safety of the operation and eliminates the need for the surgeon to wear a headlight, which improves surgical field of vision.”
The patented disposable, single-use-only device is sterile and latex-free, and is designed to be safe, simple, and economical to use. Ortho-Light is flexible and low-profile; attaches easily to virtually any retractor using a biocompatible, two-sided adhesive; and inserts directly into the surgical cavity.
For more information, contact
LumitexMD®, Inc
|
Extremity Medical, LLC, announced that it has received FDA clearance for the TrapEZX™ Anatomic Trapezium Prosthesis. The company also announced that it had received CE Mark for the product and is initiating limited release in selected centers in the United States and Europe. Extremity Medical notes that the TrapEZX Prosthesis is the first completely anatomic trapezium bone replacement available in the world.
The device is intended to treat degenerative and posttraumatic disabilities of the thumb basal joint. The TrapEZX Trapezium Replacement is the first of its kind that is anatomic and incorporates a window designed to offer the potential of hematoma encapsulation for long term stability.
For more information, contact
Extremity Medical, LLC
|
Morphine Sulfate Oral Solution
Roxane Laboratories, Inc., announced the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution Cll, 100 mg per 5 mL (20 mg/mL), 30 mL, and 120 mL bottles by the US Food and Drug Administration (FDA). This product is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
Roxane Laboratories’ Morphine Sulfate Oral Solution Cll, 100 mg per 5 mL (20 mg/mL) is the only FDA-approved Morphine Sulfate Oral Solution Cll available at this concentration. Full prescribing information for Morphine Sulfate Oral Solution Cll is available on the Roxane Laboratories website.
To learn more, contact
Roxane Laboratories, Inc. - Technical Product Information
|
New Instruments
Integra LifeSciences has introduced 4 new products. Secure-Cut™ Reposable Endoscopic Scissors are composed of a cost-effective reusable carbon fiber handle with a PEEK shaft and “always sharp” single-use scissor tips. The system includes a secure connection composed of stainless steel threading that ensures a robust, lasting connection and a protective PEEK insulation that prevents arcing.
The Ruggles™ Bayonet Curettes allow spine surgeons to see the operative field more clearly by providing an offset handle. The new line of Ruggles Curettes complements Integra’s array of neuro/spine instruments.
The Jarit® Disposable Bi-polar Forceps deliver gentle coagulation between highly polished instrument tips to minimize coagulum adhesion. This important addition to Integra’s forceps portfolio complements its Buzz™ reusable non-stick forceps.
Integra’s improved LumbarTrak™ Retractor System incorporates enhancements to the frame that provide unparalleled strength. The system is designed to help surgeons establish prompt and lasting exposure during their lumbar spine procedures.
For more information, contact
Integra Life Sciences
|
The Ortho-Light™ surgical illuminator is a new illumination solution from Lumitex MD® that helps orthopedic surgeons improve visualization in small-incision hip, shoulder, or knee surgeries.
A cool, flexible acrylic fiber optic panel that adheres to retractors, Ortho-Light dramatically improves the view of the surgical cavity with bright, shadowless, continuous area light.
“This light attaches to any retractor and provides superb visualization during preparation of the acetabulum for total hip replacement, no matter the incision,” commented Dr. Larry Dorr of the Dorr Arthritis Institute. “It improves safety of the operation and eliminates the need for the surgeon to wear a headlight, which improves surgical field of vision.”
The patented disposable, single-use-only device is sterile and latex-free, and is designed to be safe, simple, and economical to use. Ortho-Light is flexible and low-profile; attaches easily to virtually any retractor using a biocompatible, two-sided adhesive; and inserts directly into the surgical cavity.
For more information, contact
LumitexMD®, Inc
|
Extremity Medical, LLC, announced that it has received FDA clearance for the TrapEZX™ Anatomic Trapezium Prosthesis. The company also announced that it had received CE Mark for the product and is initiating limited release in selected centers in the United States and Europe. Extremity Medical notes that the TrapEZX Prosthesis is the first completely anatomic trapezium bone replacement available in the world.
The device is intended to treat degenerative and posttraumatic disabilities of the thumb basal joint. The TrapEZX Trapezium Replacement is the first of its kind that is anatomic and incorporates a window designed to offer the potential of hematoma encapsulation for long term stability.
For more information, contact
Extremity Medical, LLC
|
Morphine Sulfate Oral Solution
Roxane Laboratories, Inc., announced the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution Cll, 100 mg per 5 mL (20 mg/mL), 30 mL, and 120 mL bottles by the US Food and Drug Administration (FDA). This product is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
Roxane Laboratories’ Morphine Sulfate Oral Solution Cll, 100 mg per 5 mL (20 mg/mL) is the only FDA-approved Morphine Sulfate Oral Solution Cll available at this concentration. Full prescribing information for Morphine Sulfate Oral Solution Cll is available on the Roxane Laboratories website.
To learn more, contact
Roxane Laboratories, Inc. - Technical Product Information
|
New Instruments
Integra LifeSciences has introduced 4 new products. Secure-Cut™ Reposable Endoscopic Scissors are composed of a cost-effective reusable carbon fiber handle with a PEEK shaft and “always sharp” single-use scissor tips. The system includes a secure connection composed of stainless steel threading that ensures a robust, lasting connection and a protective PEEK insulation that prevents arcing.
The Ruggles™ Bayonet Curettes allow spine surgeons to see the operative field more clearly by providing an offset handle. The new line of Ruggles Curettes complements Integra’s array of neuro/spine instruments.
The Jarit® Disposable Bi-polar Forceps deliver gentle coagulation between highly polished instrument tips to minimize coagulum adhesion. This important addition to Integra’s forceps portfolio complements its Buzz™ reusable non-stick forceps.
Integra’s improved LumbarTrak™ Retractor System incorporates enhancements to the frame that provide unparalleled strength. The system is designed to help surgeons establish prompt and lasting exposure during their lumbar spine procedures.
For more information, contact
Integra Life Sciences
|
New Products/Product News
MedShape Solutions has launched the Morphix™ Anchor for soft-tissue repair. The device is manufactured from MedShape’s shape-memory PEEK Altera™. The dynamic wing design and PEEK Altera construction combine to produce a soft-tissue repair device with high initial fixation strength and improved cyclic loading performance. Static anchor designs subjected to cyclic loading forces typically demonstrate an incremental reduction of pullout strength and significant device migration which may ultimately lead to clinical failure. In laboratory testing, the Morphix Anchor responded positively to cyclic loading forces and retained its initial pullout strength. The Morphix Anchor is deployed into the bone using a simple and reliable tap-in technique.
The Morphix™ Anchor is supplied preloaded with multiple braided polyethylene sutures on a convenient single-use delivery handle. The Morphix Anchor is available in a range of sizes from 2.5 mm to 5.5 mm.
To learn more, contact
MedShape Solutions, Inc.
|
Neuromuscular Stimulation Device
Innovative Neurotronics, Inc., announced the launch of its Bi-Flex Cuff, the latest enhancement to its neuromuscular stimulation device called the WalkAide. The company notes that the new cuff provides patients with increased comfort, ease of use, and consistent, reproducible outcomes. The Bi-Flex Cuff is now standard with all WalkAides.
Designed to maximize the functionality and precision of the patented WalkAide tilt accelerometer, the Bi-Flex Cuff promotes multidirectional mobility and a natural gait pattern—an essential component of central nervous system retraining and recovery. The new electrode locators help ensure precise placement, resulting in a more consistent and accurate delivery of electrical impulses to lift the patient’s foot at the appropriate time in their walking cycle, something WalkAide patients cannot do for themselves. This new feature helps patients achieve the same optimal results at home as when their practitioners position the WalkAide in a clinical setting.
Additional features of the Bi-Flex Cuff include improved aesthetics, a new latch attachment system, a unique dual durometer construction (rigid side to ease one-handed donning/doffing, soft side to conform to the leg for total electrode contact), and a vented design that allows for increased air circulation and better breathability.
While the Bi-Flex Cuff now comes standard with the WalkAide, previous owners of the WalkAide can purchase the new Bi-Flex Cuff for $350. To locate a provider, visit the facility locator at www.walkaide.com/en-US/FacilityLocator.
Hanger Orthopedic Group, Inc.
|
NonSurgical Dupuytren’s Contracture Treatment
Auxilium Pharmaceuticals, Inc., has received marketing approval from the FDA for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated biologic, for the treatment of adult Dupuytren’s contracture patients with a palpable cord. The company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March.
FDA has required a risk evaluation and mitigation strategy (REMS) program for XIAFLEX, which consists of a communication plan and a medication guide. This REMS is designed to (1) evaluate and mitigate known and potential risks and serious adverse events; (2) to inform healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures; and (3) to inform patients about the serious risks associated with XIAFLEX. Auxilium plans to market XIAFLEX to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren’s contracture and will provide access to XIAFLEX only after physicians have attested to completion of a training program. The training program is available as a video or written manual and demonstrates proper use and administration of XIAFLEX as well as an overview of both identified and potential risks with XIAFLEX.
The company has established a distribution network that will allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration.
For additional information, contact
Auxilium
|
MedShape Solutions has launched the Morphix™ Anchor for soft-tissue repair. The device is manufactured from MedShape’s shape-memory PEEK Altera™. The dynamic wing design and PEEK Altera construction combine to produce a soft-tissue repair device with high initial fixation strength and improved cyclic loading performance. Static anchor designs subjected to cyclic loading forces typically demonstrate an incremental reduction of pullout strength and significant device migration which may ultimately lead to clinical failure. In laboratory testing, the Morphix Anchor responded positively to cyclic loading forces and retained its initial pullout strength. The Morphix Anchor is deployed into the bone using a simple and reliable tap-in technique.
The Morphix™ Anchor is supplied preloaded with multiple braided polyethylene sutures on a convenient single-use delivery handle. The Morphix Anchor is available in a range of sizes from 2.5 mm to 5.5 mm.
To learn more, contact
MedShape Solutions, Inc.
|
Neuromuscular Stimulation Device
Innovative Neurotronics, Inc., announced the launch of its Bi-Flex Cuff, the latest enhancement to its neuromuscular stimulation device called the WalkAide. The company notes that the new cuff provides patients with increased comfort, ease of use, and consistent, reproducible outcomes. The Bi-Flex Cuff is now standard with all WalkAides.
Designed to maximize the functionality and precision of the patented WalkAide tilt accelerometer, the Bi-Flex Cuff promotes multidirectional mobility and a natural gait pattern—an essential component of central nervous system retraining and recovery. The new electrode locators help ensure precise placement, resulting in a more consistent and accurate delivery of electrical impulses to lift the patient’s foot at the appropriate time in their walking cycle, something WalkAide patients cannot do for themselves. This new feature helps patients achieve the same optimal results at home as when their practitioners position the WalkAide in a clinical setting.
Additional features of the Bi-Flex Cuff include improved aesthetics, a new latch attachment system, a unique dual durometer construction (rigid side to ease one-handed donning/doffing, soft side to conform to the leg for total electrode contact), and a vented design that allows for increased air circulation and better breathability.
While the Bi-Flex Cuff now comes standard with the WalkAide, previous owners of the WalkAide can purchase the new Bi-Flex Cuff for $350. To locate a provider, visit the facility locator at www.walkaide.com/en-US/FacilityLocator.
Hanger Orthopedic Group, Inc.
|
NonSurgical Dupuytren’s Contracture Treatment
Auxilium Pharmaceuticals, Inc., has received marketing approval from the FDA for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated biologic, for the treatment of adult Dupuytren’s contracture patients with a palpable cord. The company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March.
FDA has required a risk evaluation and mitigation strategy (REMS) program for XIAFLEX, which consists of a communication plan and a medication guide. This REMS is designed to (1) evaluate and mitigate known and potential risks and serious adverse events; (2) to inform healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures; and (3) to inform patients about the serious risks associated with XIAFLEX. Auxilium plans to market XIAFLEX to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren’s contracture and will provide access to XIAFLEX only after physicians have attested to completion of a training program. The training program is available as a video or written manual and demonstrates proper use and administration of XIAFLEX as well as an overview of both identified and potential risks with XIAFLEX.
The company has established a distribution network that will allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration.
For additional information, contact
Auxilium
|
MedShape Solutions has launched the Morphix™ Anchor for soft-tissue repair. The device is manufactured from MedShape’s shape-memory PEEK Altera™. The dynamic wing design and PEEK Altera construction combine to produce a soft-tissue repair device with high initial fixation strength and improved cyclic loading performance. Static anchor designs subjected to cyclic loading forces typically demonstrate an incremental reduction of pullout strength and significant device migration which may ultimately lead to clinical failure. In laboratory testing, the Morphix Anchor responded positively to cyclic loading forces and retained its initial pullout strength. The Morphix Anchor is deployed into the bone using a simple and reliable tap-in technique.
The Morphix™ Anchor is supplied preloaded with multiple braided polyethylene sutures on a convenient single-use delivery handle. The Morphix Anchor is available in a range of sizes from 2.5 mm to 5.5 mm.
To learn more, contact
MedShape Solutions, Inc.
|
Neuromuscular Stimulation Device
Innovative Neurotronics, Inc., announced the launch of its Bi-Flex Cuff, the latest enhancement to its neuromuscular stimulation device called the WalkAide. The company notes that the new cuff provides patients with increased comfort, ease of use, and consistent, reproducible outcomes. The Bi-Flex Cuff is now standard with all WalkAides.
Designed to maximize the functionality and precision of the patented WalkAide tilt accelerometer, the Bi-Flex Cuff promotes multidirectional mobility and a natural gait pattern—an essential component of central nervous system retraining and recovery. The new electrode locators help ensure precise placement, resulting in a more consistent and accurate delivery of electrical impulses to lift the patient’s foot at the appropriate time in their walking cycle, something WalkAide patients cannot do for themselves. This new feature helps patients achieve the same optimal results at home as when their practitioners position the WalkAide in a clinical setting.
Additional features of the Bi-Flex Cuff include improved aesthetics, a new latch attachment system, a unique dual durometer construction (rigid side to ease one-handed donning/doffing, soft side to conform to the leg for total electrode contact), and a vented design that allows for increased air circulation and better breathability.
While the Bi-Flex Cuff now comes standard with the WalkAide, previous owners of the WalkAide can purchase the new Bi-Flex Cuff for $350. To locate a provider, visit the facility locator at www.walkaide.com/en-US/FacilityLocator.
Hanger Orthopedic Group, Inc.
|
NonSurgical Dupuytren’s Contracture Treatment
Auxilium Pharmaceuticals, Inc., has received marketing approval from the FDA for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated biologic, for the treatment of adult Dupuytren’s contracture patients with a palpable cord. The company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March.
FDA has required a risk evaluation and mitigation strategy (REMS) program for XIAFLEX, which consists of a communication plan and a medication guide. This REMS is designed to (1) evaluate and mitigate known and potential risks and serious adverse events; (2) to inform healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures; and (3) to inform patients about the serious risks associated with XIAFLEX. Auxilium plans to market XIAFLEX to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren’s contracture and will provide access to XIAFLEX only after physicians have attested to completion of a training program. The training program is available as a video or written manual and demonstrates proper use and administration of XIAFLEX as well as an overview of both identified and potential risks with XIAFLEX.
The company has established a distribution network that will allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration.
For additional information, contact
Auxilium
|
New Products/Product News
OrthoCor™ has introduced their Active Knee System™, which delivers a unique combination of soothing heat and medical therapy to provide effective pain relief where it is most needed. With its simple, compact, and flexible design, it is easy to use and helps manage knee pain so patients can maintain an active lifestyle.
The OrthoCor Active Knee System is a portable, Class III medical device that has been cleared by the FDA. It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It also provides temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis. It is safe and effective for in-home use.
To learn more, contact
OrthoCor Medical, Inc.
|
Injectable Bone Grafts
Biocomposites has launched geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the resorbable bone graft material with a negative surface charge.
The powder and liquid components of geneX are provided pre-packed in separate syringes. The syringes connect together and allow a faster, simpler, and cleaner way for mixing geneX. The resulting setting paste can then be delivered through an 8-cm dispenser (included). The company notes that geneX ds is ideal for difficult-to-reach surgical sites and minimally invasive procedures.
GeneX is a synthetic bone graft material with a unique biphasic composition manufactured through a process, ZPC® (Zeta Potential Control), that confers on the product a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation and fusion by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis. geneX is fully resorbable and is completely replaced by bone. The company notes that geneX overcomes the surgeon’s reliance on donor tissue, presenting both a cost saving and a reduction in the risks associated with its use.
geneX ds is FDA cleared and CE marked and is now available in 2.5 cc
Biocomposites Inc.
|
Spinal System
Medtronic, Inc., has announced the US launch of the SOVEREIGN™ Spinal System.
The SOVEREIGN Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. The SOVEREIGN Spinal System is designed to stabilize the spine and promote bony fusion.
To restore a patient’s disc height, surgeons have traditionally used bone grafts, stabilized and held in place by metal plates anchored to the spine with bone screws. The SOVEREIGN Spinal System incorporates a lens-shaped device with 3 holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant. The system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone (PEEK), the SOVEREIGN device is radiolucent on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.
The SOVEREIGN Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at 1 or 2 contiguous vertebral levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of nonoperative treatment. The implant may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN intervertebral body fusion device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN interbody device is intended to be used with the 3 titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than 3 or none of the provided screws, then additional supplemental fixation which has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.
For more information, contact
Medtronic
|
OrthoCor™ has introduced their Active Knee System™, which delivers a unique combination of soothing heat and medical therapy to provide effective pain relief where it is most needed. With its simple, compact, and flexible design, it is easy to use and helps manage knee pain so patients can maintain an active lifestyle.
The OrthoCor Active Knee System is a portable, Class III medical device that has been cleared by the FDA. It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It also provides temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis. It is safe and effective for in-home use.
To learn more, contact
OrthoCor Medical, Inc.
|
Injectable Bone Grafts
Biocomposites has launched geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the resorbable bone graft material with a negative surface charge.
The powder and liquid components of geneX are provided pre-packed in separate syringes. The syringes connect together and allow a faster, simpler, and cleaner way for mixing geneX. The resulting setting paste can then be delivered through an 8-cm dispenser (included). The company notes that geneX ds is ideal for difficult-to-reach surgical sites and minimally invasive procedures.
GeneX is a synthetic bone graft material with a unique biphasic composition manufactured through a process, ZPC® (Zeta Potential Control), that confers on the product a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation and fusion by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis. geneX is fully resorbable and is completely replaced by bone. The company notes that geneX overcomes the surgeon’s reliance on donor tissue, presenting both a cost saving and a reduction in the risks associated with its use.
geneX ds is FDA cleared and CE marked and is now available in 2.5 cc
Biocomposites Inc.
|
Spinal System
Medtronic, Inc., has announced the US launch of the SOVEREIGN™ Spinal System.
The SOVEREIGN Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. The SOVEREIGN Spinal System is designed to stabilize the spine and promote bony fusion.
To restore a patient’s disc height, surgeons have traditionally used bone grafts, stabilized and held in place by metal plates anchored to the spine with bone screws. The SOVEREIGN Spinal System incorporates a lens-shaped device with 3 holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant. The system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone (PEEK), the SOVEREIGN device is radiolucent on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.
The SOVEREIGN Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at 1 or 2 contiguous vertebral levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of nonoperative treatment. The implant may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN intervertebral body fusion device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN interbody device is intended to be used with the 3 titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than 3 or none of the provided screws, then additional supplemental fixation which has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.
For more information, contact
Medtronic
|
OrthoCor™ has introduced their Active Knee System™, which delivers a unique combination of soothing heat and medical therapy to provide effective pain relief where it is most needed. With its simple, compact, and flexible design, it is easy to use and helps manage knee pain so patients can maintain an active lifestyle.
The OrthoCor Active Knee System is a portable, Class III medical device that has been cleared by the FDA. It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It also provides temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis. It is safe and effective for in-home use.
To learn more, contact
OrthoCor Medical, Inc.
|
Injectable Bone Grafts
Biocomposites has launched geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the resorbable bone graft material with a negative surface charge.
The powder and liquid components of geneX are provided pre-packed in separate syringes. The syringes connect together and allow a faster, simpler, and cleaner way for mixing geneX. The resulting setting paste can then be delivered through an 8-cm dispenser (included). The company notes that geneX ds is ideal for difficult-to-reach surgical sites and minimally invasive procedures.
GeneX is a synthetic bone graft material with a unique biphasic composition manufactured through a process, ZPC® (Zeta Potential Control), that confers on the product a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation and fusion by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis. geneX is fully resorbable and is completely replaced by bone. The company notes that geneX overcomes the surgeon’s reliance on donor tissue, presenting both a cost saving and a reduction in the risks associated with its use.
geneX ds is FDA cleared and CE marked and is now available in 2.5 cc
Biocomposites Inc.
|
Spinal System
Medtronic, Inc., has announced the US launch of the SOVEREIGN™ Spinal System.
The SOVEREIGN Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. The SOVEREIGN Spinal System is designed to stabilize the spine and promote bony fusion.
To restore a patient’s disc height, surgeons have traditionally used bone grafts, stabilized and held in place by metal plates anchored to the spine with bone screws. The SOVEREIGN Spinal System incorporates a lens-shaped device with 3 holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant. The system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone (PEEK), the SOVEREIGN device is radiolucent on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.
The SOVEREIGN Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at 1 or 2 contiguous vertebral levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of nonoperative treatment. The implant may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN intervertebral body fusion device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN interbody device is intended to be used with the 3 titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than 3 or none of the provided screws, then additional supplemental fixation which has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.
For more information, contact
Medtronic
|
New Products/Product News
Enhanced Fixation Spinal System
Medtronic, Inc. has launched the TSRH® 3Dx™ Spinal System. Designed with procedural efficiency in mind, the TSRH 3Dx Spinal System offers 2 screws designed to address multiple pathologies. The Multi Planar Adjusting (MPA®) Screw option provides surgeons a variable angle posted screw for targeted, controlled correction maneuvers. The OSTEOGRIP® Screw enhances bone fixation by incorporating a dual-lead thread pattern that reduces toggle at the bone-screw interface.
Medtronic notes that this next-generation pedicle screw system includes competitive differentiating technology for addressing multiple spinal pathologies, from degenerative disc disease to spinal deformity. The system also offers CHROMALOY™ rods and a minimally invasive capability.
To learn more, contact
Medtronic
|
Pneumatic Knee Splint
Professional Products, Inc. announced its innovative new pneumatic knee splint, the PKS Cryo™. A variable compression knee splint with a breathable, anti-migration wrap, the PKS Cryo offers cost-effective relief from pain and edema in treating postoperative repairs, ligament, and soft-tissue injuries.
The migration and sag of freezable gel is a problem for products that treat soft-tissue injuries to the knee. The company notes that PKS Cryo’s revolutionary multiple compartment technology solves this problem by confining the gel to the optimal location for controlling edema. Cryotherapy is provided by the patented FirstICE® continuous cold therapy system. An average FirstICE® ice pack delivers up to 4 hours of cold therapy.
The ability of the PKS Cryo to inflate and deflate is another significant advantage in treatment because adjustable pneumatic support, combined with cryotherapy, provides more effective control of edema than cryotherapy alone.
The benefit of cryotherapy with peripheral compression increases when two modalities—cold and air—are used together. Velcro® Compatible Hyper Foam with Tricot Lining and Anti-Migration Strapping keeps the PKS Cryo in place during patient ambulation. The company notes that the splint simplifies treatment for clinicians, lowers costs, reduces swelling and pain, and provides superior comfort.
The PKS Cryo is available with a removable air-gel combo bag or fixed air bag with removable ice packs from the FirstICE® cold therapy system.
Professional Products, Inc.
|
Knee Resurfacing Application
MAKO Surgical Corp. announced the commercial availability of the Lateral Unicompartmental Knee Resurfacing Application for its RIO® Robotic Arm Interactive Orthopedic System. The new application complements MAKO’s existing unicompartmental and bicompartmental knee applications targeting the medial and patellofemoral compartments.
For more information, contact
MAKO Surgical Corp.
|
Anti-Gravity Treadmill
AlterG, Inc. has launched the AlterG M300. The company notes that the M300 delivers the same anti-gravity technology originally developed at NASA and found in AlterG’s P200 series, at a third of the price and with a sleek new design. The AlterG M300 is optimized in form, function, and price for physical therapy clinics, athletic training, and leading fitness facilities.
The company notes that AlterG enables people to rehab faster, train like a pro, or even accelerate weight loss. Allowing people to run and walk at a fraction of their body weight (reducing up to 80% of a person’s weight), AlterG’s Differential Air Pressure technology applies a precise and comfortable lifting force to the body, so people can move naturally and pain-free. Reducing body weight lowers the impact on joints and muscles to provide a smooth recovery from injury or surgery or to improve training and performance.
Originally designed for top athletes, professional and collegiate sports teams, and leading medical facilities, the AlterG benefits anyone looking to train or rehab smarter.
For more information, contact
AlterG, Inc.
|
Modular Primary Hip System
Stryker has introduced the Rejuvenate Femoral Platform—a modular hip system of femoral bodies and necks that provides surgeons with the options for personalizing the implant to each patient’s anatomy. The Rejuvenate femoral stem represents the latest evolution in the OmniFit and Secur-Fit product lines, which has had a successful published clinical history for over 15 years.1
Stryker notes that the Rejuvenate System offers the surgeon the opportunity to independently manage stem size, leg length, version, and offset. The surgeon may utilize these options to recreate the patient’s anatomy, restore biomechanics, and consequently minimize risk of dislocation.2,3
The modular junction construct is designed to maintain strength and durability. The Rejuvenate System combines the material characteristics of TMZF (Ti-12Mo-6Zr-2Fe) and cobalt chrome (CoCr) for the stem and neck implants, respectively. Laboratory testing demonstrates the compatibility of these materials without concern for fretting and corrosion.4
Stryker notes that the easy-to-use instrument design helps improve workflow due to the modular instrumentation and multiplicity of instrument usage. The instruments are also designed with enhanced ergonomics and integrated with navigation.
To learn more, contact
Stryker Orthopaedics
References
|
Unicompartmental Knee Replacement
ConforMIS, Inc. is taking the next step in the evolution of patient-specific technology by launching a new iteration of its unicompartmental knee resurfacing device, the iUni® G2. Enhancements to the iUni G2 include an improved patient-specific and wear-optimized design, instrument changes for even simpler surgical techniques, and iView™ patient-specific images for improved surgical planning.
ConforMIS’ partial knee resurfacing systems use proprietary technology and patient-specific imaging data to personalize an implant and instrumentation set for each patient, providing superior fit and performance. ConforMIS introduced the iUni G2 in November 2009, and it is currently available for both medial and lateral compartment treatment.
ConforMIS notes that its patient-specific approach offers an array of advantages to patients, surgeons, and hospitals. These benefits include patient-specific fit and wear-optimized design. The iUni G2 offers patient-specific anatomic fit for natural kinematics, full coverage of all weight-bearing areas, and a new implant designed for low-contact stress and micromotion.
With a minimally invasive and minimally traumatic procedure, patients benefit from a resurfacing solution with minimal bone resection, preservation of all ligaments, no intramedullary canal penetration, and the ability for a simple conversion to a primary total knee arthroplasty.
ConforMIS’ iUni G2 surgery uses iJig® patient-specific instrumentation to reduce the number of surgical steps and to minimize intra-operative sizing and trials. In addition, the company notes that the new iView patient-specific planning images introduce an entirely new and simple way to visualize joint preparation during surgery.
ConforMIS notes that the iUni G2 provides an assortment of efficiency benefits to surgeons and hospitals, including simplified set-up and tear-down, minimal instrumentation for surgery, complete system delivery in a disposable kit, and reduced sterilization and inventory costs.
For more information, contact
ConforMIS, Inc.
|
Lateral Osteoarthritis Brace
Orthofix International has announced that its sports medicine division, BREG, has expanded its successful line of FUSION® functional knee braces with the FUSION® Lateral OA Brace, which features an ultra-thin low-profile hinge designed for individuals suffering from lateral compartment osteoarthritis (OA).
The FUSION Lateral OA Brace was developed to off-load knee stress for individuals suffering with OA, and the low-profile hinge is designed to reduce interference during the wearer’s movement specifically on the medial part of the knee. As the newest member of the BREG family of FUSION functional knee braces, the new Lateral OA Brace is designed to provide support for the anterior cruciate ligament and posterior cruciate ligament, as well as protection for collateral ligaments, without hindering the wearer’s activity.
The FUSION Lateral OA Brace features BREG’s thumbwheel dial that allows precision off-loading adjustments without any tools. The brace’s frame also incorporates BREG’s ProForm™ technology, which uses Zytel®, a strong yet flexible polymer. Orthofix notes that this streamlined, lightweight frame was designed to conform intimately to the leg, reduce migration, promote natural motion, and provide superior protection.
The full line of FUSION braces, including FUSION, FUSION XT (for contact sports), FUSION Women’s, FUSION OA, and FUSION Lateral OA, are available in custom and off-the-shelf versions.
For more information, contact
Orthofix Sports Medicine BREG, Inc.
|
Enhanced Fixation Spinal System
Medtronic, Inc. has launched the TSRH® 3Dx™ Spinal System. Designed with procedural efficiency in mind, the TSRH 3Dx Spinal System offers 2 screws designed to address multiple pathologies. The Multi Planar Adjusting (MPA®) Screw option provides surgeons a variable angle posted screw for targeted, controlled correction maneuvers. The OSTEOGRIP® Screw enhances bone fixation by incorporating a dual-lead thread pattern that reduces toggle at the bone-screw interface.
Medtronic notes that this next-generation pedicle screw system includes competitive differentiating technology for addressing multiple spinal pathologies, from degenerative disc disease to spinal deformity. The system also offers CHROMALOY™ rods and a minimally invasive capability.
To learn more, contact
Medtronic
|
Pneumatic Knee Splint
Professional Products, Inc. announced its innovative new pneumatic knee splint, the PKS Cryo™. A variable compression knee splint with a breathable, anti-migration wrap, the PKS Cryo offers cost-effective relief from pain and edema in treating postoperative repairs, ligament, and soft-tissue injuries.
The migration and sag of freezable gel is a problem for products that treat soft-tissue injuries to the knee. The company notes that PKS Cryo’s revolutionary multiple compartment technology solves this problem by confining the gel to the optimal location for controlling edema. Cryotherapy is provided by the patented FirstICE® continuous cold therapy system. An average FirstICE® ice pack delivers up to 4 hours of cold therapy.
The ability of the PKS Cryo to inflate and deflate is another significant advantage in treatment because adjustable pneumatic support, combined with cryotherapy, provides more effective control of edema than cryotherapy alone.
The benefit of cryotherapy with peripheral compression increases when two modalities—cold and air—are used together. Velcro® Compatible Hyper Foam with Tricot Lining and Anti-Migration Strapping keeps the PKS Cryo in place during patient ambulation. The company notes that the splint simplifies treatment for clinicians, lowers costs, reduces swelling and pain, and provides superior comfort.
The PKS Cryo is available with a removable air-gel combo bag or fixed air bag with removable ice packs from the FirstICE® cold therapy system.
Professional Products, Inc.
|
Knee Resurfacing Application
MAKO Surgical Corp. announced the commercial availability of the Lateral Unicompartmental Knee Resurfacing Application for its RIO® Robotic Arm Interactive Orthopedic System. The new application complements MAKO’s existing unicompartmental and bicompartmental knee applications targeting the medial and patellofemoral compartments.
For more information, contact
MAKO Surgical Corp.
|
Anti-Gravity Treadmill
AlterG, Inc. has launched the AlterG M300. The company notes that the M300 delivers the same anti-gravity technology originally developed at NASA and found in AlterG’s P200 series, at a third of the price and with a sleek new design. The AlterG M300 is optimized in form, function, and price for physical therapy clinics, athletic training, and leading fitness facilities.
The company notes that AlterG enables people to rehab faster, train like a pro, or even accelerate weight loss. Allowing people to run and walk at a fraction of their body weight (reducing up to 80% of a person’s weight), AlterG’s Differential Air Pressure technology applies a precise and comfortable lifting force to the body, so people can move naturally and pain-free. Reducing body weight lowers the impact on joints and muscles to provide a smooth recovery from injury or surgery or to improve training and performance.
Originally designed for top athletes, professional and collegiate sports teams, and leading medical facilities, the AlterG benefits anyone looking to train or rehab smarter.
For more information, contact
AlterG, Inc.
|
Modular Primary Hip System
Stryker has introduced the Rejuvenate Femoral Platform—a modular hip system of femoral bodies and necks that provides surgeons with the options for personalizing the implant to each patient’s anatomy. The Rejuvenate femoral stem represents the latest evolution in the OmniFit and Secur-Fit product lines, which has had a successful published clinical history for over 15 years.1
Stryker notes that the Rejuvenate System offers the surgeon the opportunity to independently manage stem size, leg length, version, and offset. The surgeon may utilize these options to recreate the patient’s anatomy, restore biomechanics, and consequently minimize risk of dislocation.2,3
The modular junction construct is designed to maintain strength and durability. The Rejuvenate System combines the material characteristics of TMZF (Ti-12Mo-6Zr-2Fe) and cobalt chrome (CoCr) for the stem and neck implants, respectively. Laboratory testing demonstrates the compatibility of these materials without concern for fretting and corrosion.4
Stryker notes that the easy-to-use instrument design helps improve workflow due to the modular instrumentation and multiplicity of instrument usage. The instruments are also designed with enhanced ergonomics and integrated with navigation.
To learn more, contact
Stryker Orthopaedics
References
|
Unicompartmental Knee Replacement
ConforMIS, Inc. is taking the next step in the evolution of patient-specific technology by launching a new iteration of its unicompartmental knee resurfacing device, the iUni® G2. Enhancements to the iUni G2 include an improved patient-specific and wear-optimized design, instrument changes for even simpler surgical techniques, and iView™ patient-specific images for improved surgical planning.
ConforMIS’ partial knee resurfacing systems use proprietary technology and patient-specific imaging data to personalize an implant and instrumentation set for each patient, providing superior fit and performance. ConforMIS introduced the iUni G2 in November 2009, and it is currently available for both medial and lateral compartment treatment.
ConforMIS notes that its patient-specific approach offers an array of advantages to patients, surgeons, and hospitals. These benefits include patient-specific fit and wear-optimized design. The iUni G2 offers patient-specific anatomic fit for natural kinematics, full coverage of all weight-bearing areas, and a new implant designed for low-contact stress and micromotion.
With a minimally invasive and minimally traumatic procedure, patients benefit from a resurfacing solution with minimal bone resection, preservation of all ligaments, no intramedullary canal penetration, and the ability for a simple conversion to a primary total knee arthroplasty.
ConforMIS’ iUni G2 surgery uses iJig® patient-specific instrumentation to reduce the number of surgical steps and to minimize intra-operative sizing and trials. In addition, the company notes that the new iView patient-specific planning images introduce an entirely new and simple way to visualize joint preparation during surgery.
ConforMIS notes that the iUni G2 provides an assortment of efficiency benefits to surgeons and hospitals, including simplified set-up and tear-down, minimal instrumentation for surgery, complete system delivery in a disposable kit, and reduced sterilization and inventory costs.
For more information, contact
ConforMIS, Inc.
|
Lateral Osteoarthritis Brace
Orthofix International has announced that its sports medicine division, BREG, has expanded its successful line of FUSION® functional knee braces with the FUSION® Lateral OA Brace, which features an ultra-thin low-profile hinge designed for individuals suffering from lateral compartment osteoarthritis (OA).
The FUSION Lateral OA Brace was developed to off-load knee stress for individuals suffering with OA, and the low-profile hinge is designed to reduce interference during the wearer’s movement specifically on the medial part of the knee. As the newest member of the BREG family of FUSION functional knee braces, the new Lateral OA Brace is designed to provide support for the anterior cruciate ligament and posterior cruciate ligament, as well as protection for collateral ligaments, without hindering the wearer’s activity.
The FUSION Lateral OA Brace features BREG’s thumbwheel dial that allows precision off-loading adjustments without any tools. The brace’s frame also incorporates BREG’s ProForm™ technology, which uses Zytel®, a strong yet flexible polymer. Orthofix notes that this streamlined, lightweight frame was designed to conform intimately to the leg, reduce migration, promote natural motion, and provide superior protection.
The full line of FUSION braces, including FUSION, FUSION XT (for contact sports), FUSION Women’s, FUSION OA, and FUSION Lateral OA, are available in custom and off-the-shelf versions.
For more information, contact
Orthofix Sports Medicine BREG, Inc.
|
Enhanced Fixation Spinal System
Medtronic, Inc. has launched the TSRH® 3Dx™ Spinal System. Designed with procedural efficiency in mind, the TSRH 3Dx Spinal System offers 2 screws designed to address multiple pathologies. The Multi Planar Adjusting (MPA®) Screw option provides surgeons a variable angle posted screw for targeted, controlled correction maneuvers. The OSTEOGRIP® Screw enhances bone fixation by incorporating a dual-lead thread pattern that reduces toggle at the bone-screw interface.
Medtronic notes that this next-generation pedicle screw system includes competitive differentiating technology for addressing multiple spinal pathologies, from degenerative disc disease to spinal deformity. The system also offers CHROMALOY™ rods and a minimally invasive capability.
To learn more, contact
Medtronic
|
Pneumatic Knee Splint
Professional Products, Inc. announced its innovative new pneumatic knee splint, the PKS Cryo™. A variable compression knee splint with a breathable, anti-migration wrap, the PKS Cryo offers cost-effective relief from pain and edema in treating postoperative repairs, ligament, and soft-tissue injuries.
The migration and sag of freezable gel is a problem for products that treat soft-tissue injuries to the knee. The company notes that PKS Cryo’s revolutionary multiple compartment technology solves this problem by confining the gel to the optimal location for controlling edema. Cryotherapy is provided by the patented FirstICE® continuous cold therapy system. An average FirstICE® ice pack delivers up to 4 hours of cold therapy.
The ability of the PKS Cryo to inflate and deflate is another significant advantage in treatment because adjustable pneumatic support, combined with cryotherapy, provides more effective control of edema than cryotherapy alone.
The benefit of cryotherapy with peripheral compression increases when two modalities—cold and air—are used together. Velcro® Compatible Hyper Foam with Tricot Lining and Anti-Migration Strapping keeps the PKS Cryo in place during patient ambulation. The company notes that the splint simplifies treatment for clinicians, lowers costs, reduces swelling and pain, and provides superior comfort.
The PKS Cryo is available with a removable air-gel combo bag or fixed air bag with removable ice packs from the FirstICE® cold therapy system.
Professional Products, Inc.
|
Knee Resurfacing Application
MAKO Surgical Corp. announced the commercial availability of the Lateral Unicompartmental Knee Resurfacing Application for its RIO® Robotic Arm Interactive Orthopedic System. The new application complements MAKO’s existing unicompartmental and bicompartmental knee applications targeting the medial and patellofemoral compartments.
For more information, contact
MAKO Surgical Corp.
|
Anti-Gravity Treadmill
AlterG, Inc. has launched the AlterG M300. The company notes that the M300 delivers the same anti-gravity technology originally developed at NASA and found in AlterG’s P200 series, at a third of the price and with a sleek new design. The AlterG M300 is optimized in form, function, and price for physical therapy clinics, athletic training, and leading fitness facilities.
The company notes that AlterG enables people to rehab faster, train like a pro, or even accelerate weight loss. Allowing people to run and walk at a fraction of their body weight (reducing up to 80% of a person’s weight), AlterG’s Differential Air Pressure technology applies a precise and comfortable lifting force to the body, so people can move naturally and pain-free. Reducing body weight lowers the impact on joints and muscles to provide a smooth recovery from injury or surgery or to improve training and performance.
Originally designed for top athletes, professional and collegiate sports teams, and leading medical facilities, the AlterG benefits anyone looking to train or rehab smarter.
For more information, contact
AlterG, Inc.
|
Modular Primary Hip System
Stryker has introduced the Rejuvenate Femoral Platform—a modular hip system of femoral bodies and necks that provides surgeons with the options for personalizing the implant to each patient’s anatomy. The Rejuvenate femoral stem represents the latest evolution in the OmniFit and Secur-Fit product lines, which has had a successful published clinical history for over 15 years.1
Stryker notes that the Rejuvenate System offers the surgeon the opportunity to independently manage stem size, leg length, version, and offset. The surgeon may utilize these options to recreate the patient’s anatomy, restore biomechanics, and consequently minimize risk of dislocation.2,3
The modular junction construct is designed to maintain strength and durability. The Rejuvenate System combines the material characteristics of TMZF (Ti-12Mo-6Zr-2Fe) and cobalt chrome (CoCr) for the stem and neck implants, respectively. Laboratory testing demonstrates the compatibility of these materials without concern for fretting and corrosion.4
Stryker notes that the easy-to-use instrument design helps improve workflow due to the modular instrumentation and multiplicity of instrument usage. The instruments are also designed with enhanced ergonomics and integrated with navigation.
To learn more, contact
Stryker Orthopaedics
References
|
Unicompartmental Knee Replacement
ConforMIS, Inc. is taking the next step in the evolution of patient-specific technology by launching a new iteration of its unicompartmental knee resurfacing device, the iUni® G2. Enhancements to the iUni G2 include an improved patient-specific and wear-optimized design, instrument changes for even simpler surgical techniques, and iView™ patient-specific images for improved surgical planning.
ConforMIS’ partial knee resurfacing systems use proprietary technology and patient-specific imaging data to personalize an implant and instrumentation set for each patient, providing superior fit and performance. ConforMIS introduced the iUni G2 in November 2009, and it is currently available for both medial and lateral compartment treatment.
ConforMIS notes that its patient-specific approach offers an array of advantages to patients, surgeons, and hospitals. These benefits include patient-specific fit and wear-optimized design. The iUni G2 offers patient-specific anatomic fit for natural kinematics, full coverage of all weight-bearing areas, and a new implant designed for low-contact stress and micromotion.
With a minimally invasive and minimally traumatic procedure, patients benefit from a resurfacing solution with minimal bone resection, preservation of all ligaments, no intramedullary canal penetration, and the ability for a simple conversion to a primary total knee arthroplasty.
ConforMIS’ iUni G2 surgery uses iJig® patient-specific instrumentation to reduce the number of surgical steps and to minimize intra-operative sizing and trials. In addition, the company notes that the new iView patient-specific planning images introduce an entirely new and simple way to visualize joint preparation during surgery.
ConforMIS notes that the iUni G2 provides an assortment of efficiency benefits to surgeons and hospitals, including simplified set-up and tear-down, minimal instrumentation for surgery, complete system delivery in a disposable kit, and reduced sterilization and inventory costs.
For more information, contact
ConforMIS, Inc.
|
Lateral Osteoarthritis Brace
Orthofix International has announced that its sports medicine division, BREG, has expanded its successful line of FUSION® functional knee braces with the FUSION® Lateral OA Brace, which features an ultra-thin low-profile hinge designed for individuals suffering from lateral compartment osteoarthritis (OA).
The FUSION Lateral OA Brace was developed to off-load knee stress for individuals suffering with OA, and the low-profile hinge is designed to reduce interference during the wearer’s movement specifically on the medial part of the knee. As the newest member of the BREG family of FUSION functional knee braces, the new Lateral OA Brace is designed to provide support for the anterior cruciate ligament and posterior cruciate ligament, as well as protection for collateral ligaments, without hindering the wearer’s activity.
The FUSION Lateral OA Brace features BREG’s thumbwheel dial that allows precision off-loading adjustments without any tools. The brace’s frame also incorporates BREG’s ProForm™ technology, which uses Zytel®, a strong yet flexible polymer. Orthofix notes that this streamlined, lightweight frame was designed to conform intimately to the leg, reduce migration, promote natural motion, and provide superior protection.
The full line of FUSION braces, including FUSION, FUSION XT (for contact sports), FUSION Women’s, FUSION OA, and FUSION Lateral OA, are available in custom and off-the-shelf versions.
For more information, contact
Orthofix Sports Medicine BREG, Inc.
|