12-Month Study Reports 90% Success Rate For AMS' MiniArc Single-Incision Sling

Main Category: Urology / Nephrology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 17 Jul 2010 - 1:00 PST

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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 results of a prospective, multi-center study on their market leading MiniArc Single-Incision Sling System for female stress urinary incontinence (SUI). The study concludes that MiniArc efficacy rates for negative cough stress test (CST) and 1-hr Pad Weight Test (PWT) at 12 months were 90.6 percent and 84.5 percent, respectively.

The results of the international, multi-center, single-arm clinical trial conducted at sixteen centers in U.S., Canada, Belgium and UK, were published today in the August issue of the peer-reviewed Journal of Urology, the official journal of the American Urological Association. This data confirms the results of earlier studies from independent physicians pointing to a high degree of efficacy and patient satisfaction.

"We are very pleased to see these positive results which will help physicians and their patients feel confident that the MiniArc system will effectively treat SUI, and also significantly improve quality of life", said John Nealon, senior vice president and general manager of Women's Health at AMS.

"This study demonstrated that the MiniArc procedure is quick, carries minimal patient morbidity and is very tolerable, highlighted by short facility stays, minimal post-op discomfort and a quick return to normal activities," said Dr. Michael Kennelly, principal investigator on the study. "This multi-center prospective study shows encouraging results for the MiniArc sling as a first-line treatment for female patients with SUI. Ongoing follow-up through two years is planned."

The MiniArc Single-Incision Sling System is part of AMS' portfolio of minimally invasive solutions that treat female SUI and help to restore female urinary continence.

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 more than 335,000 patients in 2009.

Source: American Medical Systems

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