Product Review

 

 

FDA guidance for power morcellation

On December 29, 2020, the US Food and Drug Administration (FDA) issued an updated safety communication, focused on their ongoing advisement that, when laparoscopic power morcellation is appropriate, only contained morcellation should be performed. Their guidance now points out that uncontained power morcellation has been associated with the spread of benign uterine tissue, which can result in additional surgery. They recommend that health care providers conduct a thorough preoperative screening and, as part of shared decision making, discuss the risks and benefits of all relevant treatment options with their patients prior to undergoing a procedure such as myomectomy or hysterectomy.

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

For more information, visit : https://medical.olympusamerica.com/products/contained-tissue-extraction-system

Vaginal odor elimination gel

Relactagel, a vaginal odor elimination gel, has been clinically shown to maintain a healthy vaginal pH, favoring the growth of lactobacilli bacteria, according its manufacturer Kora Healthcare. These bacteria reinforce the protective acidity of the vagina by producing more lactic acid. Glycogen, also present in Relactagel, compounds existing glycogen stores in the vagina and acts as a nutrient for the lactobacilli.

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

For more information, visit: https://www.relactagel.com/.

Intrauterine electrosurgery system

Olympus announces that it has acquired the trademark of VERSAPOINT, and is now manufacturing, selling, and marketing the complete intrauterine electrosurgery system—VERSAPOINT II Bipolar Electrosurgery System. The system allows for surgeons to diagnose and treat myomas, polyps, intrauterine adhesions, and uterine septa. Olympus recommends that the Twizzle Tip electrode is ideal for tissue cutting, for septum removals, and endometrial polyp resection. And they say that the Spring Tip electrode should be used for resection or bulk vaporization of a fibroid, as it has a wider vaporizing effect than the Twizzle Tip. Olympus also points out that the VERSAPOINT II Bipolar Generator allows for energy release as needed, ensuring vaper pocket formation. It offers user control during procedures by recognizing default settings for the connected electrode and allowing for customized settings with the dual footswitch, says Olympus.

For more information, visit: https://medical.olympusamerica.com/

 

 

FDA guidance for power morcellation

On December 29, 2020, the US Food and Drug Administration (FDA) issued an updated safety communication, focused on their ongoing advisement that, when laparoscopic power morcellation is appropriate, only contained morcellation should be performed. Their guidance now points out that uncontained power morcellation has been associated with the spread of benign uterine tissue, which can result in additional surgery. They recommend that health care providers conduct a thorough preoperative screening and, as part of shared decision making, discuss the risks and benefits of all relevant treatment options with their patients prior to undergoing a procedure such as myomectomy or hysterectomy.

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

For more information, visit : https://medical.olympusamerica.com/products/contained-tissue-extraction-system

Vaginal odor elimination gel

Relactagel, a vaginal odor elimination gel, has been clinically shown to maintain a healthy vaginal pH, favoring the growth of lactobacilli bacteria, according its manufacturer Kora Healthcare. These bacteria reinforce the protective acidity of the vagina by producing more lactic acid. Glycogen, also present in Relactagel, compounds existing glycogen stores in the vagina and acts as a nutrient for the lactobacilli.

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

For more information, visit: https://www.relactagel.com/.

Intrauterine electrosurgery system

Olympus announces that it has acquired the trademark of VERSAPOINT, and is now manufacturing, selling, and marketing the complete intrauterine electrosurgery system—VERSAPOINT II Bipolar Electrosurgery System. The system allows for surgeons to diagnose and treat myomas, polyps, intrauterine adhesions, and uterine septa. Olympus recommends that the Twizzle Tip electrode is ideal for tissue cutting, for septum removals, and endometrial polyp resection. And they say that the Spring Tip electrode should be used for resection or bulk vaporization of a fibroid, as it has a wider vaporizing effect than the Twizzle Tip. Olympus also points out that the VERSAPOINT II Bipolar Generator allows for energy release as needed, ensuring vaper pocket formation. It offers user control during procedures by recognizing default settings for the connected electrode and allowing for customized settings with the dual footswitch, says Olympus.

For more information, visit: https://medical.olympusamerica.com/

 

 

FDA guidance for power morcellation

On December 29, 2020, the US Food and Drug Administration (FDA) issued an updated safety communication, focused on their ongoing advisement that, when laparoscopic power morcellation is appropriate, only contained morcellation should be performed. Their guidance now points out that uncontained power morcellation has been associated with the spread of benign uterine tissue, which can result in additional surgery. They recommend that health care providers conduct a thorough preoperative screening and, as part of shared decision making, discuss the risks and benefits of all relevant treatment options with their patients prior to undergoing a procedure such as myomectomy or hysterectomy.

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

For more information, visit : https://medical.olympusamerica.com/products/contained-tissue-extraction-system

Vaginal odor elimination gel

Relactagel, a vaginal odor elimination gel, has been clinically shown to maintain a healthy vaginal pH, favoring the growth of lactobacilli bacteria, according its manufacturer Kora Healthcare. These bacteria reinforce the protective acidity of the vagina by producing more lactic acid. Glycogen, also present in Relactagel, compounds existing glycogen stores in the vagina and acts as a nutrient for the lactobacilli.

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

For more information, visit: https://www.relactagel.com/.

Intrauterine electrosurgery system

Olympus announces that it has acquired the trademark of VERSAPOINT, and is now manufacturing, selling, and marketing the complete intrauterine electrosurgery system—VERSAPOINT II Bipolar Electrosurgery System. The system allows for surgeons to diagnose and treat myomas, polyps, intrauterine adhesions, and uterine septa. Olympus recommends that the Twizzle Tip electrode is ideal for tissue cutting, for septum removals, and endometrial polyp resection. And they say that the Spring Tip electrode should be used for resection or bulk vaporization of a fibroid, as it has a wider vaporizing effect than the Twizzle Tip. Olympus also points out that the VERSAPOINT II Bipolar Generator allows for energy release as needed, ensuring vaper pocket formation. It offers user control during procedures by recognizing default settings for the connected electrode and allowing for customized settings with the dual footswitch, says Olympus.

For more information, visit: https://medical.olympusamerica.com/

 

Updated option for breast biopsy

Hologic announces updates to its Brevera^® Breast Biopsy System with CorLumina^® Imaging Technology. The Brevera system is designed for use with the manufacturer’s Affirm^® Prone biopsy guidance system. 

Available since 2017, the Brevera system is designed to enhance the workflow for the breast biopsy procedure and overall patient experience by allowing for real-time imaging of sample acquisition. This feature avoids the need for the clinician to leave the patient exam room to verify tissue samples, saving time during the patient visit and allowing for more clinician-patient interaction. Brevera also combines tissue acquisition and real-time imaging verification with postbiopsy handling, with new functionality and simplified storage, including stowage of disposable needles, and improved waste management. The combination of the system improvements help to maintain the sample integrity, says Hologic, allowing for radiologists and technicians to handle the sample and then for the transfer to pathology. According to the manufacturer, the improved features offer facilities the potential to save an average of 13 minutes per procedure.

For more information, visit https://www.hologic.com.

“Mini-sponge” device shows potential to treat PPH

Although its research is in the pilot phase, Obstetrx, Inc. announces its XSTAT device has shown success in stopping postpartum hemorrhage (PPH) quickly. The device is a novel uterine tamponade “mini-sponge.” Contained in an applicator, XSTAT is comprised of compressed mini-sponges that are inserted into the postpartum uterus. Contained in a porous, distensible pouch, the sponges expand quickly, applying hemostatic pressure within the uterus. After a period of observation, the pouch is removed with gentle traction on the removal strand.

During a pilot study, reports Obstetrx, 9 patients, treated at the University Teaching Hospital in Lusaka, Zambia, did not respond to conventional PPH management options after vaginal birth but did respond, with bleeding resolved in 60 seconds and no adverse events, to the XSTAT device. The device was left in place for a mean time of 1 hour, and none of the patients required further surgical procedures or blood transfusions. The initial placement time of XSTAT (mean time to placement, 62 seconds) was faster than times reported for balloon uterine tamponade devices. The pilot study results were published in Obstetrics & Gynecology.

XSTAT is US Food and Drug Administration–approved to treat high-flow arterial bleeding in prehospital trauma settings, and Obstetrx is planning to submit for 510k clearance in 2022, after the conclusion of a follow-up PPH trial in 2021.

 

For more information, visit: https://www.obstetrx.com/.

Continue to: AI and ovulation prediction...

 

 

AI and ovulation prediction

The Priya Fertility System, developed by Prima-Temp, will be available over the counter soon for couples who are trying to optimize their chances for pregnancy. The system consists of an intravaginal sensor and mobile app, the first of which measures a woman’s core body temperature and the second of which alerts the user of her fertility window to maximize conception.

A woman’s fertility window is typically the 5 days leading up to ovulation, with peak fertility in the 2 to 3 days before ovulation. There are other options for measuring that fertile window, including luteinizing hormone (LH) tests; however, Prima-Temp reports that Priya predicts the fertile window an average of 2.6 days before tests for LH. Utilizing continuous core body temperature measurement, Priya detects subtle changes in temperature patterns that occur prior to ovulation. The app portion of the technology stores and analyzes the temperature measurements, for a high-tech fertility alert system that also offers clinical diagnostic support. Potential users of the Priya system are able to sign up to receive it through the product’s website.

For more information, visit: https://www.priyafertility.com.

 

Updated option for breast biopsy

Hologic announces updates to its Brevera^® Breast Biopsy System with CorLumina^® Imaging Technology. The Brevera system is designed for use with the manufacturer’s Affirm^® Prone biopsy guidance system. 

Available since 2017, the Brevera system is designed to enhance the workflow for the breast biopsy procedure and overall patient experience by allowing for real-time imaging of sample acquisition. This feature avoids the need for the clinician to leave the patient exam room to verify tissue samples, saving time during the patient visit and allowing for more clinician-patient interaction. Brevera also combines tissue acquisition and real-time imaging verification with postbiopsy handling, with new functionality and simplified storage, including stowage of disposable needles, and improved waste management. The combination of the system improvements help to maintain the sample integrity, says Hologic, allowing for radiologists and technicians to handle the sample and then for the transfer to pathology. According to the manufacturer, the improved features offer facilities the potential to save an average of 13 minutes per procedure.

For more information, visit https://www.hologic.com.

“Mini-sponge” device shows potential to treat PPH

Although its research is in the pilot phase, Obstetrx, Inc. announces its XSTAT device has shown success in stopping postpartum hemorrhage (PPH) quickly. The device is a novel uterine tamponade “mini-sponge.” Contained in an applicator, XSTAT is comprised of compressed mini-sponges that are inserted into the postpartum uterus. Contained in a porous, distensible pouch, the sponges expand quickly, applying hemostatic pressure within the uterus. After a period of observation, the pouch is removed with gentle traction on the removal strand.

During a pilot study, reports Obstetrx, 9 patients, treated at the University Teaching Hospital in Lusaka, Zambia, did not respond to conventional PPH management options after vaginal birth but did respond, with bleeding resolved in 60 seconds and no adverse events, to the XSTAT device. The device was left in place for a mean time of 1 hour, and none of the patients required further surgical procedures or blood transfusions. The initial placement time of XSTAT (mean time to placement, 62 seconds) was faster than times reported for balloon uterine tamponade devices. The pilot study results were published in Obstetrics & Gynecology.

XSTAT is US Food and Drug Administration–approved to treat high-flow arterial bleeding in prehospital trauma settings, and Obstetrx is planning to submit for 510k clearance in 2022, after the conclusion of a follow-up PPH trial in 2021.

 

For more information, visit: https://www.obstetrx.com/.

Continue to: AI and ovulation prediction...

 

 

AI and ovulation prediction

The Priya Fertility System, developed by Prima-Temp, will be available over the counter soon for couples who are trying to optimize their chances for pregnancy. The system consists of an intravaginal sensor and mobile app, the first of which measures a woman’s core body temperature and the second of which alerts the user of her fertility window to maximize conception.

A woman’s fertility window is typically the 5 days leading up to ovulation, with peak fertility in the 2 to 3 days before ovulation. There are other options for measuring that fertile window, including luteinizing hormone (LH) tests; however, Prima-Temp reports that Priya predicts the fertile window an average of 2.6 days before tests for LH. Utilizing continuous core body temperature measurement, Priya detects subtle changes in temperature patterns that occur prior to ovulation. The app portion of the technology stores and analyzes the temperature measurements, for a high-tech fertility alert system that also offers clinical diagnostic support. Potential users of the Priya system are able to sign up to receive it through the product’s website.

For more information, visit: https://www.priyafertility.com.

 

Updated option for breast biopsy

Hologic announces updates to its Brevera^® Breast Biopsy System with CorLumina^® Imaging Technology. The Brevera system is designed for use with the manufacturer’s Affirm^® Prone biopsy guidance system. 

Available since 2017, the Brevera system is designed to enhance the workflow for the breast biopsy procedure and overall patient experience by allowing for real-time imaging of sample acquisition. This feature avoids the need for the clinician to leave the patient exam room to verify tissue samples, saving time during the patient visit and allowing for more clinician-patient interaction. Brevera also combines tissue acquisition and real-time imaging verification with postbiopsy handling, with new functionality and simplified storage, including stowage of disposable needles, and improved waste management. The combination of the system improvements help to maintain the sample integrity, says Hologic, allowing for radiologists and technicians to handle the sample and then for the transfer to pathology. According to the manufacturer, the improved features offer facilities the potential to save an average of 13 minutes per procedure.

For more information, visit https://www.hologic.com.

“Mini-sponge” device shows potential to treat PPH

Although its research is in the pilot phase, Obstetrx, Inc. announces its XSTAT device has shown success in stopping postpartum hemorrhage (PPH) quickly. The device is a novel uterine tamponade “mini-sponge.” Contained in an applicator, XSTAT is comprised of compressed mini-sponges that are inserted into the postpartum uterus. Contained in a porous, distensible pouch, the sponges expand quickly, applying hemostatic pressure within the uterus. After a period of observation, the pouch is removed with gentle traction on the removal strand.

During a pilot study, reports Obstetrx, 9 patients, treated at the University Teaching Hospital in Lusaka, Zambia, did not respond to conventional PPH management options after vaginal birth but did respond, with bleeding resolved in 60 seconds and no adverse events, to the XSTAT device. The device was left in place for a mean time of 1 hour, and none of the patients required further surgical procedures or blood transfusions. The initial placement time of XSTAT (mean time to placement, 62 seconds) was faster than times reported for balloon uterine tamponade devices. The pilot study results were published in Obstetrics & Gynecology.

XSTAT is US Food and Drug Administration–approved to treat high-flow arterial bleeding in prehospital trauma settings, and Obstetrx is planning to submit for 510k clearance in 2022, after the conclusion of a follow-up PPH trial in 2021.

 

For more information, visit: https://www.obstetrx.com/.

Continue to: AI and ovulation prediction...

 

 

AI and ovulation prediction

The Priya Fertility System, developed by Prima-Temp, will be available over the counter soon for couples who are trying to optimize their chances for pregnancy. The system consists of an intravaginal sensor and mobile app, the first of which measures a woman’s core body temperature and the second of which alerts the user of her fertility window to maximize conception.

A woman’s fertility window is typically the 5 days leading up to ovulation, with peak fertility in the 2 to 3 days before ovulation. There are other options for measuring that fertile window, including luteinizing hormone (LH) tests; however, Prima-Temp reports that Priya predicts the fertile window an average of 2.6 days before tests for LH. Utilizing continuous core body temperature measurement, Priya detects subtle changes in temperature patterns that occur prior to ovulation. The app portion of the technology stores and analyzes the temperature measurements, for a high-tech fertility alert system that also offers clinical diagnostic support. Potential users of the Priya system are able to sign up to receive it through the product’s website.

For more information, visit: https://www.priyafertility.com.