Press Releases on Medical Equipment

NEWARK, Del., Oct. 17, 2024 (GLOBE NEWSWIRE) -- A new study published last week in the “Journal of Clinical Medicine” has revealed promising results for sacrospinous ligament (SSL) fixation using the EnPlace^® device, a minimally invasive approach to pelvic organ prolapse (POP) repair.

The research, one of the largest to date with 331 patients, found that SSL fixation offers a safe and effective approach for significant apical POP, particularly in women aged 65 and older, and highlights the EnPlace^® device as a minimally invasive alternative to traditional more invasive treatments, which typically show higher recurrence rates.

For the study, patients were divided into two groups: older (mean age 71.8 years) and younger (mean age 47.6 years). Both the older and younger patients experienced high satisfaction rates, quick recovery times and minimal complications compared to typical prolapse procedures, proving the procedure's effectiveness across all age groups. Compared to results of studies of more invasive procedures, there was a lower incidence of extended periods of hospitalization or intensive care, especially among older women.

“This study provides valuable data showing that the EnPlace^® device offers women of all ages a minimally invasive repair approach with quicker recovery times and fewer complications compared to traditional prolapse procedures,” said Renee Selman, Co-CEO of FEMSelect, the developer of EnPlace^®. “These findings emphasize that women, especially older patients, do not have to suffer in silence. There is a treatment that is minimally invasive and can improve their quality of life without associated surgical risks.”

Key Findings:

• High patient satisfaction: 99.4% of patients across all age groups were discharged either the same day or the day after surgery, with high levels (>90%) of patient satisfaction reported based on anatomical cure rates and no regrets about the procedure.
• Faster recovery and minimal complications: Recovery times were short compared to traditional more invasive prolapse procedures, with most patients (99.4%) in all age groups discharged on the day of surgery or the day after. Complication rates remained low, with no significant differences in surgery duration (roughly 25 minutes) or blood loss between the groups. Seven (2.6%) older patients experienced early postoperative obstructed defecation, which was easily resolved with stool softeners.
• Low recurrence rates: The study showed low recurrence rates of POP that required additional surgery – 2.2% in older patients and 6.7% in younger patients. These recurrence rates are impressive when compared to traditional more invasive POP surgeries, where recurrence rates typically range between 20% and 30%. The higher recurrence in the younger patient population is likely due to the resumption of vigorous activities too soon after surgery.
• Reduced need for additional surgery: While results showed younger patients were slightly more likely to require additional surgery within the six-month follow-up period, the durability of the procedure was evident across all age groups.

POP affects millions of women, and while more invasive surgical options have been available, they often come with higher risks, especially for older women. One in four women over the age of 18 experiences symptoms of prolapse, and women have historically faced limited treatment options due to concerns about recovery time and potential complications.

"With the aging population expected to triple by 2050, it is critical that we have safe, effective options for older women experiencing pelvic organ prolapse," said Dr. Ronen S. Gold, one of the study's authors. "EnPlace^® is a minimally invasive technique that offers an approach that may significantly improve quality of life while minimizing surgical risks, making it a valuable option for women in their later years."

For more information on the study, visit https://www.mdpi.com/2077-0383/13/18/5520

For more information on EnPlace^®, visit https://femselect.com/enplace-technology/

About FEMSelect and 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.

The EnPlace^® system is a novel minimally invasive device for transvaginal sacrospinous ligament fixation with no need for extensive dissection or mesh. For more information about the EnPlace^® system, please contact info@femselect.com.

Media Contact:
Lauren Stralo
PR Director
lstralo@levlane.com
484-747-0172