02.17.14
American Medical Systems Inc. (AMS), a subsidiary of Endo Health Solutions, has received U.S. Food and Drug Administration 510(k) clearance of a transvaginal sling to treat female stress urinary incontinence (SUI).
Developed in collaboration with doctors, the RetroArc Retropubic Sling System incorporates new enhancements and the ability to make fine-tuned adjustments to better meet physicians' needs. The system is designed with AMS mesh that contains a patented adjustment suture; carefully considered needles; and an ergonomic, quick-release handle to maximize comfort and control for doctors performing the procedure. The system also has been cleared for sale in Europe.
"FDA Clearance of the RetroArc Retropubic Sling System rounds out the AMS family of slings," said Steve Blum, AMS general manager of Women's Health. "It underscores our commitment to physicians and patients for the treatment of female stress urinary incontinence."
SUI is considered the most common type of bladder leakage, impacting more than 13 million American women and 245 million worldwide, according to industry statistics.
"I found the RetroArc Retropubic Sling System to be easy to use," said Neeraj Kohli, M.D., of Newton Wellesley Hospital and Brigham and Women's Hospital in Boston, Mass., who performed the first U.S. implant of the sling. "It combines all the positive features of retropubic sling systems into one solution. I look forward to using the RetroArc System with more of my patients who suffer from female stress urinary incontinence."
Headquartered in Minnetonka, Minn., AMS is a supplier of medical devices and procedures to treat benign prostatic hyperplasia, incontinence, sexual dysfunction, and other pelvic disorders in men and women. Last summer, the firm settled $54.5 million in lawsuit stemming from injuries caused by its transvaginal mesh surgical products.
AMS is an operating company of Endo Health Solutions Inc., a specialty healthcare company with four distinct business segments focused on branded and generic pharmaceuticals, devices, and services.
a subsidiary of Endo Health Solutions
Developed in collaboration with doctors, the RetroArc Retropubic Sling System incorporates new enhancements and the ability to make fine-tuned adjustments to better meet physicians' needs. The system is designed with AMS mesh that contains a patented adjustment suture; carefully considered needles; and an ergonomic, quick-release handle to maximize comfort and control for doctors performing the procedure. The system also has been cleared for sale in Europe.
"FDA Clearance of the RetroArc Retropubic Sling System rounds out the AMS family of slings," said Steve Blum, AMS general manager of Women's Health. "It underscores our commitment to physicians and patients for the treatment of female stress urinary incontinence."
SUI is considered the most common type of bladder leakage, impacting more than 13 million American women and 245 million worldwide, according to industry statistics.
"I found the RetroArc Retropubic Sling System to be easy to use," said Neeraj Kohli, M.D., of Newton Wellesley Hospital and Brigham and Women's Hospital in Boston, Mass., who performed the first U.S. implant of the sling. "It combines all the positive features of retropubic sling systems into one solution. I look forward to using the RetroArc System with more of my patients who suffer from female stress urinary incontinence."
Headquartered in Minnetonka, Minn., AMS is a supplier of medical devices and procedures to treat benign prostatic hyperplasia, incontinence, sexual dysfunction, and other pelvic disorders in men and women. Last summer, the firm settled $54.5 million in lawsuit stemming from injuries caused by its transvaginal mesh surgical products.
AMS is an operating company of Endo Health Solutions Inc., a specialty healthcare company with four distinct business segments focused on branded and generic pharmaceuticals, devices, and services.