American Medical Systems® Inc. (AMS), has announced that its RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI) has gained CE Mark approval.
Background
So-called Stress Urinary Incontinence (SUI) is the most common type of urinary incontinence, affecting over 245 million women worldwide. SUI results in the accidental loss of urine when coughing, laughing, sneezing or during heavy lifting, or simply getting up from a chair.
American Medical Systems (AMS), a subsidiary of Endo Health Solutions Inc. and leading provider of devices and therapies for male and female pelvic health, is a diversified supplier of medical devices and procedures to treat benign prostatic hyperplasia (BPH), incontinence, sexual dysfunction, and other pelvic disorders in men and women.
The AMS RetroArc Retropubic Sling System is designed with what the company refers to as its time-tested AMS™ mesh with a patented adjustment suture; carefully considered needles; and ergonomic, quick-release handle designed to maximize comfort and control for the physician during the procedure.
Developed in collaboration with leading physicians, this system maintains familiar features of transvaginal retropubic sling systems while incorporating new enhancements and the ability to make fine-tuned adjustments to better meet the needs of physicians.
Physician comments
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. In addition to the introduction of a new product, it is beneficial to have physician training and AMS will support this in the same way they have in the past.”
Company comments
“At AMS, we are committed to providing world-class medical devices that improve patients’ quality of life,” said Camille Farhat, AMS President. “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.”
Source: American Medical Systems, Inc., PR Newswire
published: December 9, 2013 in: Approval/Clearance, Urology