American Medical Systems Holdings, a subsidiary of Endo Health Solutions (NSDQ:ENDP), landed FDA 510(k) clearance 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 13 million women in the U.S., according to a press release.
"FDA Clearance of the RetroArc retropubic sling system rounds out the AMS family of slings," women’s health general manager Steve Blum said in prepared remarks. "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."
This is another win for the Minneapolis-based medical device company. The RetroArc was cleared for use in Europe earlier this month.
