American Medical Systems, a provider of devices and therapies for male and female pelvic health, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its RetroArc retropubic sling system.
Designed for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency.
In collaboration with leading physicians, the RetroArc retropubic sling system has been 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.
RetroArc retropubic sling system has a time-tested AMS mesh with an adjustment suture and ergonomic, quick-release handle that provides consistent mesh placement, while maximizing comfort and control.
The adjustment suture allows for intra-operative adjustment without suburethral sling distortion and the RetroArc retropubic system needle provides an intuitive and familiar surgical experience.
American Medical Systems president Camille Farhat noted the company is 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," said Farhat. "We support our products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies," Farhat added.
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.
