SUNNYVALE, Calif., Nov. 20, 2014 /PRNewswire/ — The acceptance of two abstracts on the LIFE Study at the 2014 AAGL Global Congress demonstrates continued interest in the Eclipse System, the first vaginal insert designed to provide bowel control. One of the abstracts, presented by Catherine Matthews, MD, Associate Professor and Division Chief of Urogynecology and Reconstructive Pelvic Surgery at the University of North Carolina, won an Award for Best Written Abstract on Urogynecology/Pelvic Floor Disorders/Vaginal Surgery.
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), served as the National Principal Investigator of the LIFE trial and presented an abstract on the primary endpoint. These results, previously reported at the 2014 AUGS/IUGA Scientific Meeting, showed that at one month, 86% of patients in the per protocol cohort (79% in the intent-to-treat cohort) experienced treatment success. No device-related serious adverse events were observed and women experienced a significant improvement in quality of life. The LIFE study followed 61 women who experienced accidental bowel leakage twice or more per week and used the Eclipse System (consisting of an Insert and a pump) for one month.
Dr. Matthews presented an analysis of both predictors of fitting success with the Eclipse as well as an analysis of the impact of the Eclipse on various stool types. This analysis showed that women with previous prolapse surgery, shorter vaginal length, and vaginal atrophy, were less likely to achieve a successful fit. Once successfully fit, women who used the Eclipse System experienced a significant reduction in all types of episodes: solid and liquid, major and minor, and episodes with and without a sense of urgency.
“I am thrilled to be sharing this new technology and clinical analysis with the AAGL community,” said Dr. Matthews. “Understanding the nuances and predictors leading to fitting success will be important to clinicians in approaching patient selection and counseling.”
Miles Rosen, CEO of Pelvalon, commented, “We have a strong commitment to clinical research, and it is exciting to see such a positive reception to the LIFE pivotal study results. We congratulate Dr. Matthews, Dr. Richter, and the entire LIFE investigator team on the Best Abstract award.”
Over 20 million U.S. women suffer from loss of bowel control, also referred to as Fecal Incontinence (FI) or Accidental Bowel Leakage (ABL). Women who have experienced pregnancy, childbirth, or nerve or muscle damage in the pelvic region are at particular risk for bowel control problems. Many women suffer in silence, fearing accidents and restricting their daily activities, because of the embarrassing stigma around the condition and the lack of successful, non-invasive treatments.
Both abstracts were presented in the Urogynecology plenary session on Thursday, November 20, 2014 at the AAGL 2014 Global Congress in Vancouver, Canada.
About Vaginal Bowel Control and the Eclipse System
Restoring bowel control through the vagina is a new concept. The Eclipse System includes a vaginal insert which 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-invasive and non-surgical treatment option.
The Eclipse System is limited by federal law to investigational use only and is not available for sale.
Headquartered in Sunnyvale, California, privately held Pelvalon aims to improve the lives of women who suffer from bowel control problems. Founded in 2010, Pelvalon’s groundbreaking 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.