American Medical Systems obtains FDA 510(k) clearance for RetroArc retropubic sling system

10 December 2013 (Last Updated December 10th, 2013 06:32)

American Medical Systems, a subsidiary of Endo Health Solutions, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its RetroArc retropubic sling system.

American Medical Systems, a subsidiary of Endo Health Solutions, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its RetroArc retropubic sling system.

The device is designed for the treatment of SUI, which is considered the most common type of bladder leakage, impacting more than 13 million women in the US.

In collaboration with leading physicians, the RetroArc retropubic sling system is intentionally designed to maintain the familiar features of transvaginal retropubic sling systems that work, while incorporating new enhancements and fine-tuned adjustments to meet the needs of physicians.

The RetroArc Retropubic Sling System is designed with time-tested AMS mesh with an adjustment suture and ergonomic, quick-release handle.

"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 system needle provides an intuitive and familiar surgical experience. The quick-release handle has been specifically designed to provide consistent mesh placement, while maximising comfort and control.

The retropubic sling system 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.

Some of the most common risks with the RetroArc system include urinary tract infections, urge symptoms and urinary retention.

American Medical Systems president Camille Farhat said: "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."

With the launch of the RetroArc system, AMS provides a comprehensive portfolio of female continence products that include Minislings, Transobturator slings, and Retropubic slings.

Minislings offer a single-incision approach, Transobturator slings facilitate an 'outside in' approach, and Retropubic slings allow surgeons to take a 'top down' or 'bottom up' transvaginal retropubic approach.

This month, the company obtained the CE Mark approval in the European Union for its RetroArc retropubic sling system.

According to GlobalData estimates, the US incontinence devices market was valued at $2.79bn in 2012 and is expected to grow at CAGR of 5.5% to reach $4.06bn by 2019.