Healthcare Industry News: erectile dysfunction
News Release - October 8, 2007
Clinical Study of American Medical Systems' Female Stress Urinary Incontinence Product Wins Top HonorsStudy Compares Monarc(R) Subfascial Hammock to Tension-free Vaginal Tape
MINNEAPOLIS--(HSMN NewsFeed)--American Medical Systems Holdings, Inc. (NASDAQ:AMMD ) today announced that a prospective, randomized clinical trial comparing its MonarcŪ Subfascial Hammock device to a competing product won the "Prize Clinical Paper" award at the American Urogynecologic Society's (AUGS) 28th Annual Scientific Meeting.
Dr. Matthew Barber of Cleveland Clinic presented the study titled, "A Multi-Center Randomized Trial Comparing the Monarc Transobturator Tape with Tension-free Vaginal Tape for the Surgical Treatment of Stress Urinary Incontinence."
"The results of this clinical trial demonstrate that Monarc performs as well as the TVT procedure, which many have considered the gold standard for treating stress urinary incontinence," Dr. Barber said. "Our study also showed that Monarc was associated with fewer complications. We appreciate the recognition AUGS has bestowed on our work."
About the Study
The study confirms Monarc works as well as TVT for female stress urinary incontinence. Although several studies have previously compared Monarc to TVT, many were retrospective or did not have adequate sample size or length of follow up to rigorously evaluate the equivalency of these two techniques.
This multi-center, prospective randomized trial demonstrates Monarc is not inferior to TVT with a mean follow up of more than fifteen months. Monarc demonstrates non-inferiority for the primary outcome of "abnormal bladder function," which captures both efficacy and common lower urinary tract adverse events. These adverse events are defined as the presence of any of the following: incontinence symptoms-any type (ISI greater than 0), a positive cough stress test, re-treatment for stress urinary incontinence or postoperative urinary retention assessed one year after surgery. Peri-operative complications were infrequent and similar between the two groups with the exception of bladder perforations, which occurred less frequently in those who received the Monarc device.
This study further supports the safety, efficacy and patient satisfaction of Monarc that has already been established through 34 clinical articles and 94 abstracts.
This study was funded in part by a research grant from American Medical Systems; however, the company had no role in the study design, implementation, analysis or preparation of the study abstract.
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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