Retropubic sling system gets FDA 510(k) clearance

December 16, 2013

The FDA has granted 510(k) clearance for American Medical Systems, Inc.’s RetroArc retropubic sling system for treatment of female stress urinary incontinence.

The FDA has granted 510(k) clearance for American Medical Systems, Inc.’s RetroArc retropubic sling system for treatment of female stress urinary incontinence.

Developed in collaboration with leading physicians, this 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, according to AMS.

The company says the RetroArc system is designed with time-tested AMS mesh 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.

"I found the RetroArc retropubic sling system to be easy to use. 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,” said Neeraj Kohli, MD, of Newton Wellesley Hospital, Newton, MA, and Brigham and Women's Hospital, Boston, who performed the first U.S. implant of the sling on Dec. 2, 2013.

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