Hologic, Inc. (Nasdaq: HOLX) has announced the launch of its next-generation NovaSure® ADVANCED global endometrial ablation (GEA) system in the United States. The system has been FDA approved.
The NovaSure system is designed to reduce abnormal uterine bleeding (AUB) by applying radiofrequency energy to the endometrium, gently ablating the lining of the uterus in two minutes or less.1 The NovaSure ADVANCED device offers a slimmer 6 mm diameter designed to improve patient comfort and physician ease-of-use while maintaining the clinical efficacy of the trusted NovaSure system.
The NovaSure ADVANCED device has a smaller sheath size requiring less cervical dilation than the 8 mm NovaSure device, which is the current standard of care. By minimizing the dilation required, physicians can reduce patient discomfort when performing the NovaSure procedure in an office setting.
The updated device is also equipped with an acorn-like shaped cervical seal that creates an increased sealing surface within the cervical canal and provides 13% more "working length" than the previous device.2 Additional enhancements include rounded Smooth Access™ tips to simplify insertion† and a blue handle that serves as a useful reminder for how the device should be inserted.
The NovaSure ADVANCED system launched in Europe, Canada and Australia in 2016.
"I have relied on the NovaSure system for years and it has proven superior to other endometrial ablation modalities, offering a safe, effective and rapid treatment to heavy menstrual bleeding," said Dr. Francis Gardner, Consultant Gynaecologist at the Queen Alexandra Hospital in Portsmouth, England. "The introduction of the NovaSure ADVANCED system is a significant advancement. In addition to providing a more comfortable experience for patients due to the smaller diameter, physicians, like myself, will be able to perform more procedures in office, while maintaining the same efficacy of the trusted NovaSure system."
Abnormal uterine bleeding is a condition that affects one in five women and can be lifestyle-restricting.3 NovaSure endometrial ablation is a one-time procedure that can be performed either in the doctor's office or the operating room. The procedure is safe and effective, dramatically reducing or stopping menstrual bleeding in 90% of women.4 More than 2.5 million women have chosen the NovaSure procedure to treat abnormal uterine bleeding.2
"The next-generation NovaSure ADVANCED system promises the same efficacy and safety profile that physicians have trusted for more than 10 years," said Dr. Edward Evantash, Medical Director, Hologic. "As a part of our ongoing commitment to our customers, we evolved the NovaSure system to provide the enhancements our customers requested to improve physician ease-of-use and ensure an optimal patient experience."
For more information on NovaSure ADVANCED, visit www.novasure.com/ADVANCED.
- NovaSure Instructions for Use
- Hologic Inc., Data on file, 2016
- Centers for Disease Control and Prevention. Blood disorders in women: heavy menstrual bleeding. http://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html. Accessed September 24, 2015
- Cooper J, Gimpleson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):418-428
Source & Image Credit: Hologic