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