12-Month Study Reports Efficacy Rates for AMS’ Elevate Apical and Posterior Prolapse Repair System
MINNEAPOLIS, Sept. 21 /PRNewswire/ – American Medical SystemsÃ‚® (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 ElevateÃ‚® 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 Posterior Prolapse Repair System is part of American Medical Systems’ comprehensive portfolio of products designed to treat female incontinence and pelvic floor conditions. For more information about AMS’ complete line of female pelvic health solutions, visit www.americanmedicalsystems.com.
About American Medical Systems:
American Medical Systems, headquartered in Minnetonka, Minnesota, is a diversified supplier of medical devices and procedures to cure stress incontinence, erectile dysfunction, benign prostatic hyperplasia (BPH), pelvic floor 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 treat more than 335,000 patients in 2009.
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 2009 and its other SEC filings.
SOURCE American Medical Systems