FEMSelect Ltd., a women-led company developing innovative technologies to make a lasting impact on women's health, today announced positive results from a large six-month safety and outcome study of EnPlace® in 123 women with pelvic organ prolapse, published in the International Journal of Gynecology & Obstetrics(IJGO).
The article, titled The EnPlace® sacrospinous ligament fixation—A novel minimally invasive transvaginal procedure for apical pelvic organ prolapse repair: Safety and short-term outcome results,1 discusses how investigators found that EnPlace, cleared by the FDA for attaching sutures to ligaments of the pelvic floor, is a safe and effective minimally invasive system for apical pelvic organ prolapse repair, either uterine or vaginal vault prolapse.
This large retrospective cohort study included 123 consecutive patients – ages 42 through 84 – with stage III and IV apical pelvic organ prolapse who underwent transvaginal sacrospinous ligament (SSL) fixation by EnPlace. Of the 91 (74%) patients with uterine prolapse, 83 (91.2%) patients experienced no recurrent uterine prolapse during the six-month follow-up. Of the 32 (26%) patients with preoperative vault prolapse, 30 (93.6%) experienced no recurrent vault prolapse.
These study results were presented during the 2023 International Urogynecology Association 48th Annual Meeting in The Hague, Netherlands, on June 22, 2023, by Ronen Gold, MD, faculty at the department of urogynecology, of the LIS Women's Center Tel Aviv, Israel and a co-author on the study.
"EnPlace is proven as safe and effective in women affected by pelvic organ prolapse, and it is ideal for those seeking a minimally invasive procedure. FEMSelect is proud to offer solutions that dramatically improve outcomes for women, underscoring the need for innovation in women's healthcare," said Karla Loken, DO, FACOOG, chief medical officer of FEMSelect.
Authors of the study also reported that the patients who participated had no intraoperative or early postoperative complications. A median score of 87.3 was obtained (scale from 0 to 100) when patients were asked whether their preoperative symptoms were improved.
Professor Menahem Neuman, head of urogynecology at Raphael Hospital and Ben Gurion University, Beer Sheba, Israel, founder and medical director of FEMSelect, and an author of the study stated, "These positive results demonstrate that EnPlace can be considered for patients needing apical pelvic organ prolapse repair."
Other study results showed that the EnPlace approach is particularly valuable in patients with comorbidities, such as patients with contraindications to general anesthesia, patients with a high probability of adhesions in the abdominal cavity or pelvis and patients for whom a transabdominal approach may pose technical difficulties.
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