NEWARK, Del., July 13, 2022 /PRNewswire/ -- FEMSelect, the developer of EnPlace®, a minimally invasive, meshless approach to pelvic floor ligament fixation, reported positive study results for the EnPlace system on women between the ages of 33-45. The accepted abstract demonstrated overwhelmingly that the EnPlace approach to the management of symptomatic uterine prolapse in young women reached a very high level of patient satisfaction.
Lead author Masha Ben Zvi, MD, University College London Hospitals NHS Foundation Trust, Urogynecology and Pelvic Floor Surgery unit, presented the data at the American Urogynecologic Society (AUGS) and International Urogynecological Association (IUGA) international scientific meeting held in Austin, Texas, June 15-18, 2022.
At the presentation, Dr. Ben Zvi reported that EnPlace's mean operating time was only 33 minutes and the mean blood loss was only 32 ml. For the sacrospinous ligament fixation (SSLF) hysteropexy procedure, the overall patient satisfaction rate was 92.5 percent out of 100. She noted the patients all had stage 2-3 symptomatic uterine prolapse and were seeking surgical treatment. Ben Zvi stated that all women were discharged on the operative day except one who went home the following day. No short-term complications occurred as the study showed that all patients' uteri were successfully returned to the anatomically correct position (post-procedure POP-Q C-point was -5).
"This focused study on younger women confirms our overall experience with utilizing the EnPlace procedure over the past four years. The procedure is extremely safe, can be performed in an outpatient setting, and preserves the uterus while restoring normal pelvic anatomy. Furthermore, our patients really appreciate the minimal discomfort and relatively quick return to normal daily living activities," confirmed co-author Vincent Lucente, MD, Chief of Urogynecology, St. Luke's University Health Network, Bethlehem, PA.
FEMSelect's patented EnPlace delivery system enables the precise guidance, insertion and deployment of a small, nitinol anchor for pelvic floor ligament fixation. The approach is performed with minimal dissection. EnPlace has FDA 510(k) clearance and the CE Mark in the EU.
"In this era, when broadening women's healthcare choices is of the utmost importance, EnPlace's minimally invasive system provides an option that is quicker with a shorter recovery period than typical vaginal procedures," stated Debbie Garner, Co-CEO of FEMSelect.
LiNA Medical USA is the national distributor for the EnPlace system.
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.
SOURCE FEMSelect
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