FEMSelect announced positive results from a four-year prospective follow-up evaluation of its EnPlace system.
Newark, Delaware-based FEMSelect designed its EnPlace system as a minimally invasive, meshless approach to pelvic floor ligament fixation. The device attaches sutures to ligaments of the pelvic floor. It represents an alternative to heavily scrutinized pelvic mesh devices.
Medical investigators found that the FDA-cleared EnPlace produced long-term apical repair success in women treated through this method.
Post-procedure impact demonstrated a success rate of 92.3% for 13 women aged 48-82 suffering from advanced pelvic organ prolapse (POP). The evaluated procedures in the study were conducted in 2014 and 2015. Analysis measured anatomical and functional cure rates, post-operative pain and dyspareunia levels, urinary symptoms, and post-operative complication rates.
Results from the single-arm study were published in the International Journal of Gynecology and Obstetrics. Authors reported no interoperative complications in the study. They also observed no new cases of de novo pelvic pain and no new onset of bowel symptoms.
“These positive study results demonstrate that in the long and medium term, EnPlace should be considered for patients needing apical suspension and while avoiding complications from mesh augmentation, deep surgical dissection, and more invasive transvaginal or abdominal POP surgeries,” said Professor Alexander Tsivian, chair of the Urology Department, Wolfson Medical Center, Holon, Israel.
EnPlace offers an easy and fast approach to prolapse repair, FEMSelect says. It is performed with minimal dissection and without a mesh implant. The company’s patented delivery system enables precise guidance, insertion and deployment of a small nitinol anchor for pelvic floor ligament fixation. EnPlace holds FDA 510(k) clearance and CE mark approval in Europe.
“The EnPlace minimally invasive procedure reduces the recovery time and medical costs associated with transvaginal surgeries. FEMSelect is proud to bring our proven approach to the market and promote advancement in women’s healthcare,” said Debbie Garner, Co-CEO of FEMSelect.