FDA Clears AMS RetroArc™ Retropubic Female Stress Urinary Incontinence Sling

Pelvic Health device specialist American Medical Systems® Inc. (AMS), has announced FDA 510(k) Clearance of its RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI). The company says its system maintains familiar features of transvaginal retropubic sling systems while incorporating new enhancements and the ability to make fine-tuned adjustments to better meet the needs of physicians.

Background

More than 13 million women in the United States reportedly suffer from SUI, with slings being the surgical standard of care in treating these women. The RetroArc Retropubic Sling System, part of AMS’s comprehensive portfolio of female incontinence products, is designed with time-tested AMS™ mesh. This is coupled with a patented adjustment suture, carefully considered needles and an ergonomic, quick-release handle designed to maximize comfort and control for the physician during the procedure.

The AMS portfolio of female continence products includes Minislings that offer a single-incision approach, Transobturator Slings that facilitate an “outside in” approach and Retropubic Slings that allow surgeons to take a “top down” or ‘bottom up” transvaginal retropubic approach.

Physician comments

“I found the RetroArc Retropubic Sling System to be easy to use,” said Dr. Neeraj Kohli of Newton Wellesley Hospital and Brigham and Women’s Hospital, Boston, MA who performed the first US implant of the sling on December 2nd. “It combines all the positive features of retropubic sling systems into one well-designed solution. I look forward to using the RetroArc System with more of my patients who suffer from female stress urinary incontinence.”

Company comments

“FDA Clearance of the RetroArc Retropubic Sling System rounds out the AMS family of slings,” says 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, and builds on our leadership in Women’s Health.”

“At AMS, we are committed to providing world-class medical devices that improve patients’ quality of life,” said Camille Farhat, AMS president. “The RetroArc Retropubic Sling System is another example of how AMS innovates to provide world-class medical devices for patients around the world,” said Farhat. “We support our products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies.”

Source: American Medical Systems, Inc., PR Newswire

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