02.03.14
European regulators have given CE Mark approval to American Medical Systems Holdings, a subsidiary of Endo Health Solutions, 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 industry data.
"CE mark approval of the RetroArc Retropubic Sling System rounds out the AMS family of slings," said Steve Blum, AMS general manager of women's health.
The RetroArc Retropubic Sling System is designed with AMS mesh with a patented adjustment suture; carefully considered needles; and ergonomic, quick-release handle designed to maximize comfort and control for doctors performing the procedure.
According to Professor Ralf Tunn, Coordinator of the German Pelvic Floor Center, Chief Physician of Urogynecology, Berlin, Germany, "A retropubic sling with a bottom-up approach is a useful option in the treatment path of incontinence. AMS is now rounding out their product portfolio."
The Minnesota-based company settled $54.5 million in lawsuits last summer. The lawsuits, filed since 2008 in federal and state courts nationwide, accused AMS of causing injuries with its transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence.
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 industry data.
"CE mark approval of the RetroArc Retropubic Sling System rounds out the AMS family of slings," said Steve Blum, AMS general manager of women's health.
The RetroArc Retropubic Sling System is designed with AMS mesh with a patented adjustment suture; carefully considered needles; and ergonomic, quick-release handle designed to maximize comfort and control for doctors performing the procedure.
According to Professor Ralf Tunn, Coordinator of the German Pelvic Floor Center, Chief Physician of Urogynecology, Berlin, Germany, "A retropubic sling with a bottom-up approach is a useful option in the treatment path of incontinence. AMS is now rounding out their product portfolio."
The Minnesota-based company settled $54.5 million in lawsuits last summer. The lawsuits, filed since 2008 in federal and state courts nationwide, accused AMS of causing injuries with its transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence.