American Medical Systems Holdings, a subsidiary of Endo Health Solutions (NSDQ:ENDP), won CE Mark approval in the European Union for its RetroArc retropubic sling system.
The device was designed for the treatment of stress urinary incontinence. SUI is considered the most common type of bladder leakage, impacting 245 million women worldwide, according to a press release.
“At AMS, we are committed to providing world-class medical devices that improve patients’ quality of life. The RetroArc Retropubic Sling System is another example of how AMS innovates to provide world-class medical devices for patients around the world. We support our products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies,” president Camille Farhat said in prepared remarks.
The Minnesota-based company settled $54.5 million in lawsuits in June. The lawsuits, filed since 2008 in federal and state courts around the country, accused AMS of causing injuries with its transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence.