NEWARK, Del., Sept. 13, 2022 /PRNewswire/ -- FEMSelect, the developer of EnPlace®, a minimally invasive, meshless approach to pelvic floor ligament fixation, reported positive results in a four-year prospective follow-up evaluation of the system. Medical investigators found that EnPlace, cleared by the FDA for attaching sutures to ligaments of the pelvic floor, produced long-term apical repair success for women treated by this method.
The post-procedure impact showed a surgical success rate of 92.3% for the 13 women aged 48 through 82 who suffered from advanced Pelvic Organ Prolapse (POP). The EnPlace procedures were conducted in 2014 and 2015. The analysis measured anatomical and functional cure rates, post-operative pain and dyspareunia levels, urinary symptoms, and post-operative complication rates. The single-arm study was published in the International Journal of Gynecology and Obstetrics.
Professor Alexander Tsivian, Chairman of Urology Department, Wolfson Medical Center, Holon, Israel stated, "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."
The authors reported that the women in the study had no interoperative complications, no new cases of de novo pelvic pain, and no new onset of bowel symptoms.
The EnPlace system makes an approach to prolapse repair easy and fast to perform with minimal dissection and without a mesh implant. FEMSelect's patented delivery system enables the precise guidance, insertion and deployment of a small, nitinol anchor for pelvic floor ligament fixation. EnPlace has FDA 510(k) clearance and the CE Mark in the EU.
"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," commented Debbie Garner, Co-CEO of FEMSelect.
LiNA Medical USA is the national distributor for the EnPlace system.
Prof. Menahem Neuman, a study author, is Medical Director of FEMSelect.
FEMSelect is a women-led company with a mission to make a lasting impact on women's health by delivering innovative technologies that provide consistent results in a patient-centric manner and dramatically improve outcomes for women. For more information about the EnPlace system, please contact [email protected] or visit https://femselect.com.