Device company Pelvalon has announced the publication of results from the LIFE study, a clinical evaluation of the Eclipse System, the first vaginal insert designed to address loss of bowel control.
Over 20 million U.S. women suffer from loss of bowel control for reasons related to pregnancy, childbirth, or nerve or muscle damage in the pelvic region. Many women suffer in silence, fearing accidents and restricting their daily activities, because of the embarrassing stigma around the condition and the limited options for successful, non-invasive treatments.
Californian device company Pelvalon aims to change the lives of women who suffer from bowel control problems. Its ground-breaking technology originated from Stanford University’s Biodesign program, a collaboration between the schools of medicine and engineering. Pelvalon’s investors include Norwich Ventures, a specialized venture capital firm focused on medtech.
Restoring bowel control through the vagina is a new concept. The Eclipse System includes a vaginal insert that is placed in the same location as a tampon, and a special pump for inflating and deflating a balloon on the insert. The balloon is designed to occlude the rectum to protect against unwanted stool passage. Women can remove the insert at any time. The Eclipse System is intended to offer women a non-surgical treatment option.
The study is available online and will be published in the March 2015 issue of Obstetrics & Gynecology (the Green Journal). This is the first peer-reviewed article describing the Eclipse System, intended for women with accidental bowel leakage (ABL), also known as fecal incontinence, a condition that affects over 20 million U.S. women.
The LIFE study followed 61 women at 6 sites across the US who experienced bowel accidents twice or more per week prior to use with the Eclipse System for one month. The study results, previously reported at the 2014 AUGS/IUGA Scientific Meeting, showed that at one month, 86% of women in the per protocol cohort experienced treatment success (79% reported treatment success in the intent-to-treat cohort). No device-related serious adverse events were observed and women reported a significant improvement in quality of life. 98% of trial participants said they would recommend the Eclipse to a friend.
“The LIFE study results indicate that Eclipse, which is currently under FDA review, may offer an important new therapeutic option for women with ABL. I hope that the Green Journal publication will help raise awareness among clinicians about the prevalence of this condition and a new potential solution,” said Holly E. Richter, Ph.D, M.D., Director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham and immediate Past President of the Society for Gynecological Surgeons (SGS), who served as the National Principal Investigator of the LIFE trial and lead author on the paper.
Miles Rosen, CEO of Pelvalon, commented, “Clinical evidence is fundamental to the development of new technologies. The acceptance of these study results by a prestigious peer-reviewed journal is an important milestone for Eclipse, and I congratulate Dr. Richter and the world-renowned investigators that led this study.”
Source: PR Newswire