American Medical Systems, a subsidiary of Endo International, has announced the enrollment of first patient in the Embrace study evaluating the safety and efficacy of its Elevate anterior and apical prolapse repair system.
The multi-center, cohort-controlled, Embrace study is designed to compare the Elevate anterior and apical prolapse repair system with a native tissue repair control group.
Stanford University School of Medicine Urogynecology and Pelvic Reconstructive Surgery co-chief Dr Eric Sokol is the principal investigator for the 522 post market surveillance study.
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. Dr Richard Bercik of Yale Gynecological Oncology in New Haven, Connecticut, has completed the first patient procedure in the Embrace study.
The Embrace study is expected to enroll about 494 patients at approximately 40 sites throughout the US.
American Medical Systems is also planning to conduct Harmony study, a 522 post market surveillance study to evaluate its Elevate posterior and apical prolapse repair system. This study is expected to also enroll 494 patients at 40 participating sites.
The Embrace and Harmony studies will take approximately two years to enroll and three years to follow for a total duration of five years.
American Medical Systems president Camille Farhat said that these studies demonstrate the commitment of the company to provide medical evidence that further validates the safety and efficacy of its products.