AMS800 Artificial Urinary Sphincter Approved For Use In Japan

Main Category: Urology / Nephrology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 23 Oct 2009 - 23:00 PDT

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American Medical Systems® (AMS) (NASDAQ: AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, 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.

Source
American Medical Systems