Endo International of Malvern and American Medical Systems Inc. have announced they have enrolled their first patient in Embrace, a study focused on treating pelvic organ prolapse.
The FDA requires that all manufacturers of transvaginal mesh products conduct a post market surveillance study to determine the risks compared to the benefits of this approach to treating prolapse. With pelvic organ prolapse, the tissues that hold the pelvic organs in place become weak or stretched, resulting in the displacement (prolapse) of the pelvic organs from their normal position. Common causes are pregnancy childbirth, obesity and genetics.
Principal investigator for the Embrace study is Dr. Eric Sokol, co-chief of Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine. The controlled study will compare the Elevate Anterior and Apical Prolapse Repair System with a native tissue repair control group.
“Pelvic organ prolapse is often complex,” said Dr. Sokol. “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,” he said.
Other doctors involved in the study are Dr. Michael Ingber from the Center for Specialized Women’s Health, Division of Garden State Urology in New Jersey, and Dr. Richard Bercik of Yale Gynecological Oncology in New Haven, Conn. 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.
Endo International is a global specialty healthcare company focused on improving patients’ lives while creating shareholder value. AMS, a division of Endo, is headquartered in Minnesota and is a diversified supplier of medical device technology.
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