MINNEAPOLIS, May 12, 2011 /PRNewswire/ -- American Medical
Systems® (AMS) a leading provider of world-class devices and
therapies for male and female pelvic health, announced today the
signing of a research grant contract for six sites to evaluate
anatomical, functional and safety outcomes of two different
treatments for vaginal prolapse, Anterior Colporrhaphy, a technique
which uses traditional suture plication, versus the Elevate®
Anterior and Apical Prolapse Repair System.
"This pivotal study encompasses a highly scientific-based
approach bringing together some of the most respected physicians in
the country," said John Nealon,
Senior Vice President and General Manager at AMS. "This trial
reinforces AMS' commitment to producing high-caliber scientific
data, giving physicians the confidence in knowing they have
selected the most appropriate technique for treating their
patients."
Previous studies of mesh reinforced repairs have focused
primarily on vaginal anatomy. The goal of this study is to
more thoroughly address vaginal and lower urinary tract function in
addition to safety and efficacy. Upon completion of 12 and 24
months follow up, the objective is to have evidence for guiding the
selection of the optimal surgical procedure for patients undergoing
transvaginal prolapse repairs.
The study, which will include a total of 214 patients, will be
prospective, randomized, single blinded, and conducted at six
participating centers. Mayo Clinic is the managing site for the
study and has selected the six independent implanting sites which
it will manage throughout the study including one located in
Germany and five in the United States. The first patient
enrollment is targeted for the second half of 2011.
Elevate is a minimally invasive, comprehensive solution to treat
anterior and apical defects. The total transvaginal approach is
designed to minimize tissue trauma by offering safe, simple and
precise apical mesh placement in the sacrospinous ligament and
obturator internus muscle through a single vaginal incision.
Elevate is the top-selling vaginal mesh kit on the market and since
its introduction in 2008, more than 35,000 patients have been
treated.
The Elevate 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 2010 and its
other SEC filings.
SOURCE American Medical Systems