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12-Month Study Reports Efficacy Rates for AMS' Elevate Apical and Posterior Prolapse Repair System
Date:9/21/2010

MINNEAPOLIS, Sept. 21 /PRNewswire/ -- American Medical Systems® (AMS) (Nasdaq: AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, today announced the results of a 12-month single-arm, prospective multi-center study of the Elevate® Apical and Posterior Prolapse Repair System.  The pelvic organ prolapse quantification exam (POP-Q), used to quantify, describe, and stage pelvic support, was implemented in the study and concluded efficacy rates of Stage 1 or less to be 89.2% for Apical and 91.7% for Posterior.

The results presented at IUGA/ICS meeting also show that 98.4% of patients treated with the Elevate system would recommend the procedure to a friend.  The study was conducted at sixteen centers in the U.S., Canada, Belgium and UK.

Elevate is a minimally invasive, comprehensive solution to treat apical and posterior defects.  The total transvaginal approach is designed to minimize tissue trauma.  Elevate offers safe, simple and precise apical mesh placement in the sacrospinous ligament through a single vaginal incision.

"Our findings indicate that Elevate offers a prolapse repair technique that is safe with low morbidity and minimal postoperative pain," said Dr. James Lukban, principal investigator of the study.  "Our study concluded that Elevate Apical and Posterior is effective in terms of anatomic correction and improvement in day-to-day symptoms at one year, with ongoing analysis through 24 months."

"Over 34 million women worldwide are affected by vaginal prolapse.  This study provides reliable data that can help patients and their doctors make decisions about treatment options to improve quality of life and restore pelvic anatomy," stated John Nealon, senior vice president and general manager of Women's Health at AMS.

The Elevate Apical and Post
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SOURCE American Medical Systems
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