American Medical Systems Inc. (AMS) tells us its started enrolling in Embrace™, AMS’s 522 post market surveillance study for the Elevate™ Anterior and Apical Prolapse Repair System. The FDA has required post market surveillance studies be conducted by all manufacturers for transvaginal mesh products currently on the market, to determine the risks compared to the benefits of this approach to treating prolapse.
Pelvic organ prolapse is a condition in which the tissues that hold the pelvic organs in place become weak or stretched, resulting in the displacement of the pelvic organs from their normal position.
American Medical Systems Inc. (AMS), an Endo International plc subsidiary and leading provider of medical technologies for pelvic health, developed the Elevate™ Anterior and Apical Prolapse System, a surgical mesh kit intended for the transvaginal surgical treatment of women with anterior wall prolapse and vaginal apical prolapse.
The Embrace Study is one of the largest clinical trials ever performed by American Medical Systems, and the largest to date involving the Elevate Anterior and Apical Prolapse Repair System. It is anticipated that there will be 494 patients enrolled in the Embrace study at approximately 40 sites throughout the United States. Concurrently, AMS plans another 522 post market surveillance study, Harmony™, for the Elevate™ Posterior and Apical Prolapse Repair System, which is expected to also enroll 494 patients at 40 participating sites. Each study will take approximately 2 years to enroll and 3 years to follow for a total duration of 5 years, making these studies significantly longer than other mesh clinical trials of similar design.
Dr. Eric Sokol, Co-Chief, Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine, is the principal investigator for the Embrace study. The study is designed as a large multi-center cohort-controlled study that compares Elevate Anterior and Apical Prolapse Repair System with a native tissue repair control group.
The first patient enrolled in the study was by Dr. Michael Ingber from the Center for Specialized Women’s Health, Division of Garden State Urology in New Jersey. The first patient procedure completed in the study was performed by Dr. Richard Bercik of Yale Gynecological Oncology in New Haven, Conn.
“Pelvic organ prolapse is often complex. Multiple treatment options are needed to address the exact nature and complexity of the prolapse and there are particular circumstances when the placement of transvaginal mesh may be beneficial and appropriate. The Embrace study will provide valuable information to clinicians and patients about the role of mesh for the treatment of female pelvic organ prolapse,” said Dr. Sokol.
“These studies demonstrate the commitment of AMS to provide medical evidence that further validates the safety and efficacy of our products,” said Camille Farhat, president of American Medical Systems. “As a global leader in Women’s Health, we will continue to invest in the science that supports these therapies and maintain our support of robust physician training as well as patient education that encourages conversations about the risks and benefits of these treatments.”
Source: American Medical Systems, Inc., PR Newswire