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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
|