AMMD AdVance XP Gets CE Mark

Leading pelvic-health devices maker American Medical Systems (AMMD) reported that it received the European CE mark for its AdVance XP sling system for the treatment of male stress urinary incontinence (SUI). AdVance XP is the next-generation successor to American Medical’s AdVance (launched in August 2006) minimally invasive sling system for mild SUI.

Male SUI, which is characterized by an involuntary loss of urine, affects roughly 5 million men in the U.S. It is a common side effect of prostate cancer and benign prostatic hyperplasia (enlarged prostate) treatments such as prostatectomy (surgical removal of the prostate) and transurethral resection of the prostate (TURP). The condition is often caused by prostate abnormality, urinary tract infection, neurological disorders and aging.

Slings are the most commonly used surgical procedure for SUI. It typically consists of a narrow ribbon-shaped synthetic mesh material or a biomaterial (derived from bovine, porcine or patient’s own tissue) that is placed under the urethra through incisions to restore normal bladder control.

AdVance XP has been powered with extended features to support better performance, ease-of-use and improved clinical outcomes. Compared to its predecessor, it offers better holding power (enabled by distinct tissue anchors), improved procedural consistency and size (longer arms) to accommodate larger patients.

American Medical has already commenced a soft launch of AdVance XP in Europe with a full-scale launch expected in late 2010. The company has filed its application with the Food and Drug Administration (FDA) for approval in the U.S.

Minnesota-based American Medical is a world leader in manufacturing medical devices and procedures for treating health problems of both men and women. In addition to U.S., the company sells its products in Canada, Asia, Australia, Europe and South America.

American Medical derives nearly half of its revenues from its Men’s Health business, which comprises erectile restoration, male continence and prostate treatments. Revenues from Men’s Health continue to be boosted by higher demand for the erectile restoration and male continence product lines.

American Medical has a leading share in the male continence product market. The company competes head-to-head with Boston Scientific (BSX) and C.R. Bard (BCR) in this treatment market. AdVance XP represents another significant addition to American Medical’s male continence solutions line-up, further reinforcing the company’s leadership.

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