ACell, a regenerative medicine company, has enrolled the first patient for a US Phase IV clinical trial to assess the safety and long-term effectiveness of its MatriStem Pelvic Floor Matrix device for the treatment of pelvic organ prolapse.
First patient in the Phase IV clinical trial was enrolled at Princeton Urogynecology. The prospective, non-randomized trial will evaluate post-operative pelvic pain, quality of life and long-term need for retreatment.
The multi-center clinical trial is designed to evaluate the safety and effectiveness of MatriStem Pelvic Floor Matrix compared to native tissue repair treatment over a three-year follow up period. The study will enroll 162 subjects at qualified sites across the US.
ACell said that the study is part of its plan to conduct postmarket surveillance for MatriStem Pelvic Floor Matrix in response to the 522 Order issued to all manufacturers of transvaginal pelvic meshes by the US Food and Drug Administration (FDA) in January 2012.
ACell CEO Jim DeFrancesco said that the company will be partnering with a group of surgeons to demonstrate the safety and effectiveness of MatriStem devices in pelvic floor repair.
"We remain committed to this product category and to meeting the growing demand for devices that promote constructive remodeling," DeFrancesco added.
The FDA had approved multiple 510(k) clearances for MatriStem devices. MatriStem Pelvic Floor Matrix is designed for implantation to reinforce soft tissue where weakness exists in gynecological anatomy including vaginal prolapse repair, reconstruction of the pelvic floor and pubourethral support.