Endo International subsidiary American Medical Systems (AMS) has started patient enrolment in Embrace, its 522 post-market surveillance study for the Elevate anterior and apical prolapse repair system.
The FDA has required post-market surveillance studies to be carried out 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.
The trial is designed as a large multi-centre cohort-controlled study that compares 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 Eric Sokol said pelvic organ prolapse is often complex and 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,” Sokol said, principal investigator for the Embrace study.
A total of 494 patients are expected to be enrolled in the Embrace study at around 40 sites throughout the US.
Simultaneously, the company plans another 522 post-market surveillance study, Harmony, for the Elevate posterior and apical prolapse repair system, which is also expected to enrol 494 patients at 40 participating sites.
The company said that each study will take two years to enrol and three years to follow for a total duration of five years, making these studies significantly longer than other mesh clinical trials of similar design.
American Medical Systems president Camille Farhat said: “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.”