FDAnews Device Daily Bulletin

American Medical Systems Garners 510(k) Approval for RetroArc Sling System

Dec. 12, 2013

American Medical Systems announced Monday that the FDA has green-lighted its RetroArc Sling System for the treatment of female incontinence due to urethral hypermobility or intrinsic sphincter deficiency. The 510(k) clearance was granted on Nov. 21, the Endo Health Solutions subsidiary said.

The RetroArc sling rounds out AMS’ product line of devices to treat benign prostatic hyperplasia, incontinence, sexual dysfunction and pelvic disorders in men and women. “This will round out our portfolio,” said spokesman Brian O’Donnell. “It provides features that are unique for surgeons.”

The sling consists of a mesh, an adjustment suture and unique delivery needles with conical tips that provide smooth needle passage without deflection and flexing. The needles also can curve up to 110 degrees, allowing them to easily follow the trajectory of the pubic bone, O’Donnell said. The ergonomic quick-release handle was designed according to physician feedback for comfort of use.

AMS’ RetroArc sling is already available in the U.S. and was used for the first time on Dec. 2, O’Donnell said. The device, which is CE-marked, is also available in 25 other countries, mostly in Europe. — Lena Freund

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