American Medical Systems Inc. (AMS), an Endo Health Solutions Inc. subsidiary and leading provider of devices and therapies for male and female pelvic health, has received the US FDA 510(k) clearance for its RetroArc Retropubic Sling System for treatment of female stress urinary incontinence (SUI). 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.

With the launch of the RetroArc System, AMS provides a comprehensive portfolio of female continence products, including 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.

"US 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."

More than 13 million women in the United States suffer from SUI. Slings are the surgical standard of care in treating these women. The RetroArc Retropubic Sling System is designed with time-tested AMS mesh with a patented adjustment suture; carefully considered needles; and 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," said Dr Neeraj Kohli of Newton Wellesley Hospital and Brigham and Women's Hospital, Boston, Massachusetts. A who performed the first US implant of the sling on December 2. "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."

"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."

The RetroArc Retropubic Sling System is designed to treat women with incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency. It is contraindicated in patients who are pregnant, have active infection or signs of tissue necrosis, have known sensitivity or allergy to propylene mesh products or in patients with pre-existing conditions that pose unacceptable surgical risk.

AMS is a diversified supplier of medical devices and procedures to treat benign prostatic hyperplasia (BPH), incontinence, sexual dysfunction, and other pelvic disorders in men and women.