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Clinical Study of American Medical Systems' Female Stress Urinary Incontinence Product Wins Top Honors.


Study Compares Monarc([R]) Subfascial Hammock to Tension-free Vaginal Tape

MINNEAPOLIS -- American Medical Systems Holdings, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AMMD AMMD Aerodynamic Mass Median Diameter ) today announced that a prospective, randomized clinical trial randomized clinical trial,
n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies.
 comparing its Monarc([R]) Subfascial Hammock device to a competing product won the "Prize Clinical Paper" award at the American Urogynecologic Society's (AUGS AUGS American Urogynecologic Society ) 28th Annual Scientific Meeting.

Dr. Matthew Barber of Cleveland Clinic presented the study titled, "A Multi-Center Randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 Trial Comparing the Monarc Transobturator Tape with Tension-free Vaginal Tape for the Surgical Treatment of Stress Urinary Incontinence stress urinary incontinence
n.
See stress incontinence.
."

"The results of this clinical trial demonstrate that Monarc performs as well as the TVT TVT

transmissible venereal tumor.
 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>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 benign prostatic hyperplasia
n. Abbr. BPH
A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine.
, incontinence, menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea.

men·or·rha·gia
n.
See hypermenorrhea.
, prolapse prolapse

Protrusion of an internal organ out of its normal place, usually of the rectum or uterus outside the body when supporting muscles weaken. The membrane lining the rectum can push out through the anus, most often in old people with constipation who strain during
 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.
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Publication:Business Wire
Article Type:Clinical report
Date:Oct 8, 2007
Words:495
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