Six-Month Prospective Multi-Center Study Reports Efficacy Rates for AMS’ Elevate Anterior and Apical Prolapse Repair System
MINNEAPOLIS, March 10, 2011 /PRNewswire/ — American Medical SystemsÃ‚® (AMS) (Nasdaq: AMMD), a leading provider of world-class devices and therapies for male and female pelvic health, today announced the results of a six-month prospective multi-center study of the ElevateÃ‚® Anterior and Apical 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 One or less to be 86.3% for Anterior and 98.8% for Apical.
The study was conducted with 142 women who were enrolled at 16 centers located in the United States and Europe. When questioned about quality of life benefits after receiving the procedure, 94.7 percent of patients reported feeling some or a lot of improvement.
“The Elevate Anterior and Apical system, completed with a single vaginal incision and no external needle passes, has shown at six months to be effective at treating both anterior and apical prolapse,” said Dr. Edward J. Stanford, principal investigator of the study. “The results of this study were especially significant given that many of the patients had severe Stage Three or Four prolapse.”
Elevate is a minimally invasive, comprehensive solution to treat anterior and apical 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.
“We are very pleased to see these positive efficacy rates coupled with significant patient satisfaction,” stated John Nealon, senior vice president and general manager of Women’s Health at AMS. “This data continues to validate our technology and helps confirm why Elevate is the top-selling prolapse repair system in the market place.”
The Elevate Anterior and Apical Prolapse Repair System is part of American Medical Systems’ comprehensive portfolio of products designed to treat female incontinence and pelvic floor prolapse. 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 treat 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 approximately 340,000 patients in 2010.
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