American Medical Systems, Inc.: AMS800 Artificial Urinary Sphincter Approved for Use in Japan

Published: Oct 22, 2009

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MINNETONKA, Minn.--(BUSINESS WIRE)--American Medical Systems®, a leading provider of world-class devices and therapies for both male and female pelvic health, today announced that it has received clearance from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market and distribute its AMS 800 Artificial Urinary Sphincter (AUS) in Japan, effective September 7, 2009.

The AMS 800 has been used for nearly 30 years to restore urinary continence in almost 130,000 patients around the world. The long-term safety and efficacy of the AMS 800 have made it the gold standard treatment for moderate to severe stress urinary incontinence (SUI), which can be an unfortunate side effect of prostate cancer surgery. According to a recent survey conducted by the Japanese Urological Association approximately 16,000 radical prostatectomies were performed in Japan in 2004.

The AMS 800 is a medical device which is implanted and completely concealed inside the patient’s body. The device effectively controls the flow of urine and restores continence. This first-of-its-kind product in Japan offers incontinent patients an alternative to traditional pad and diaper therapy.

“We are very excited to offer this treatment to incontinent men in Japan,” said Michael Ryan, Vice President and General Manager of Asia Pacific, Latin America and Canada at AMS. “Although the incidence of prostate cancer is lower in Japan than in the West, it is on the increase.”

AMS is currently working with a select group of physicians to develop Centers of Excellence throughout Japan, which will serve as resources and training centers for physicians interested in implanting the AMS 800. As a next step, AMS will seek to obtain national reimbursement through the MHLW Insurance Bureau.

“We are very grateful to the Japanese Urological Association and Japanese Neurogenic Bladder Society for recognizing the importance of the AUS,” Ryan said. “AMS is eager to begin working with our identified Centers of Excellence as we strive to offer this product to every Japanese patient whose quality of life could be improved through the use of this technology.

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), prolapse 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 320,000 patients in 2008.

Forward-Looking Statements

Statements contained in this press release that are not purely historical fact are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on management's current beliefs, expectations and certain assumptions and involve risks and uncertainties which could cause actual results to differ materially from those contained in such statements. These risks and uncertainties relate to market opportunities, future products, sales and financial results of American Medical Systems. Please see our most recent Annual Report on Form 10-K, as well as our subsequent filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release are made as of the date hereof, and we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

Contacts

SS|PR Media Contact: Lisa Kornblatt 847-415-9330 lkornblatt@sspr.com or American Medical Systems Investor Relations Contact: Mark Heggestad 952-930-6495 mark.heggestad@AMMD.com

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