American Medical Systems® (AMS) (Nasdaq: AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, announced today the company received CE (Conformite Europeenne) Mark for AdVance XP. The device is the latest generation of AMS' AdVance sling, a minimally invasive implant for the treatment of male stress urinary incontinence (SUI). Male SUI is an unfortunate and common side effect of prostate cancer and benign prostatic hyperplasia (BPH) treatments, such as radical prostatectomy and transurethral resection of the prostate (TURP).
Built on the trusted success of the AdVance platform, AdVance XP incorporates additional features that are designed to deliver Xtra Performance for improved ease-of-use and clinical outcomes. Enhancements include a redesigned sling that incorporates a new mesh designed to improve procedural reproducibility, longer arms that are easier to use in larger patients and distinct tissue anchors that increase holding power during the critical healing period, following implantation.
"With AdVance XP, we are solidifying our best-in-class male sling status," said Whitney Erickson, vice president and general manager for men's health at AMS. "These enhanced features are designed to provide improvements to the AdVance male sling platform that lead to even greater reliability and procedural consistency."
The first AdVance XP implant was performed by Professor Francois Haab on July 12 at Tenon Hospital in Paris, France. "The AdVance XP sub-urethral sling is a substantial and positive evolution of the existing AdVance sling," Haab commented. "AdVance XP maximizes the already very satisfactory results that have been published with AdVance."
AMS has launched AdVance XP with a focused group of urologists throughout Europe with full-scale launch anticipated by the end of the year. AMS has filed for Food and Drug Administration (FDA) clearance. Pending required regulatory clearances, U.S. commercialization will commence.
SOURCE American Medical Systems, Inc.