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 i…