The Medical Device Business Journal — Medical Device News & Articles | MassDevice
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 took place 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 researchers published the results of their single-arm study in the International Journal of Gynecology and Obstetrics. The authors reported no inter-operative complications in the study. In addition, they 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.
Meshless pelvic floor fixation technology matters, considering pelvic mesh is arguably one of the medical device industry’s significant failures so far in the 21st century. The technology ensnared a host of big medtech companies in costly litigation.
The mesh products were supposed to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. However, complaints mounted as women reported pain, excessive bleeding and loss of sexual function. The FDA in 2019 ordered Boston Scientific and Coloplast — the remaining companies selling the devices — to halt pelvic mesh distribution. At that point, there were already thousands of lawsuits and millions of dollars worth of settlements
Filed Under: Clinical Trials, Featured, Gynecological, News Well, Women's Health Tagged With: FEMSelect
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