FemSelect yesterday said it closed enrollment in the EnPlace post-market study of its mesh-free pelvic floor repair device.
The Tel Aviv, Israel-based company enrolled 60 female patients aged 36 to 84 years at 15 sites in the U.S., Germany and Israel for the global, two-phase study. The observational study will assess the long-term safety, durability of clinical effectiveness and cost-effectiveness of the EnPlace system for vaginal colpopexy in uterine prolapse treatment.
EnPlace is designed for pelvic floor ligament fixation during prolapse repair procedures. It is a mesh-free and dissection-less approach to minimally invasive pelvic floor ligament fixation. EnPlace was FDA cleared in 2016 for attaching sutures to pelvic floor ligaments, according to the company.
The study is estimated to be completed by Aug. 31, 2024, according to a ClinicalTrials.gov.
FemSelect plans to do a limited launch in the U.S. in Q4 2019 following a Round B fundraising.