American Medical Systems Receives CE Mark for AdVanceÂ® Xtra Performance (XP) Male Sling System
MINNETONKA, Minn., Aug. 9 /PRNewswire-FirstCall/ — American Medical SystemsÃ‚® (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.
For more information about AdVance, visit www.americanmedicalsystems.com.
About American Medical Systems:
American Medical Systems, headquartered in Minnetonka, Minnesota, is a diversified supplier of medical devices and procedures to cure incontinence, erectile dysfunction, benign prostate hyperplasia (BPH), pelvic floor repair and other pelvic disorders in men and women. These disorders can significantly diminish one’s quality of life and profoundly affect social relationships. In recent years, the number of people seeking treatment has increased markedly as a result of longer lives, higher-quality-of-life expectations and greater awareness of new treatment alternatives. American Medical Systems’ products reduce or eliminate the incapacitating effects of these diseases, often through minimally invasive therapies. The Company’s products were used to treat approximately 335,000 patients in 2009.
More information about the Company and its products can be found at its website www.AmericanMedicalSystems.com and in the Company’s Annual Report on Form 10-K for 2008 and its other SEC filings.
SOURCE American Medical Systems, Inc.