Healthcare Industry News:  benign prostatic hyperplasia 

Devices Urology FDA

 News Release - March 22, 2007

American Medical Systems Has Initiated a Clinical Evaluation for a New Minimally Invasive Sling Intended to Treat Female Stress Urinary Incontinence

New MiniArc(TM) Single Incision Sling System Reduces Invasiveness and Enhances Patient Recovery

MINNEAPOLIS--(HSMN NewsFeed)--American Medical Systems Holdings, Inc. (NASDAQ:AMMD ) announced today that it has received FDA clearance and CE mark for the MiniArc(TM) Single Incision Sling System, a new, less invasive treatment for female stress urinary incontinence. AMS has already begun enrolling patients in a clinical evaluation to better understand safety, efficacy and physician training needs. MiniArc is the latest addition to the AMS family of sling products, which includes the market-leading Monarc® Transobturator Subfascial Hammock, the SPARC® Suprapubic Sling System and the innovative BioArc® hybrid slings.

The MiniArc sling system involves a simple, single incision procedure designed to reduce operative invasiveness and enhance patient recovery. MiniArc incorporates the proven mesh used in other AMS slings with a simple-to-use delivery system for easy mesh placement without additional skin incisions required with most other sling procedures. It is designed for use in the operating room; however, its low profile design and simple procedure may also make it appropriate for in-office use. AMS intends to study an office based application for the MiniArc.

MiniArc is currently being evaluated in a limited number of global sites to provide physicians the opportunity to assess the effectiveness and ease-of-use of this innovative device prior to broad distribution. Martin J. Emerson, President and CEO of AMS, commented, "We are very excited about the potential of the MiniArc sling; however, we intend to meet our commitment to physicians and patients to provide clinical information supporting its use before we make the product widely available. This approach worked well for us with Apogee® and Perigee®, and we will follow a similar path to market with MiniArc as well. We look forward to completing our evaluation and introducing MiniArc globally later this year."

Professor Dirk J.M.K. De Ridder, MD, PhD, of University Hospitals KU Leuven, Belgium, the first surgeon to implant MiniArc, said, "I am pleased with the outcome of the initial implants. MiniArc has a simple design and is easy to use. The fixation system provides strong holding force, allowing for effective tissue integration and healing into the mesh. I like the fact that AMS chose to use the same proven mesh that has been so successful in their other products."

Ross A. Longhini, Executive Vice President and Chief Operating Officer of AMS, added, "AMS is committed to continuing our leadership position in this market by providing physicians with a less-invasive technology to treat female stress urinary incontinence. The breadth of our product line signifies our commitment to meeting the changing trends in this environment. We are excited about the strength of our product pipeline and continuing to work with physicians on next generation technologies."

About American Medical Systems

American Medical Systems, headquartered in Minnetonka, Minnesota, is a diversified supplier of medical devices and procedures to cure erectile dysfunction, benign prostatic hyperplasia, incontinence, menorrhagia, 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 provide approximately 240,000 patient cures in 2006.

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 2006 and its other SEC filings.


Source: American Medical Systems Holdings

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