SUNNYVALE, Calif.–(BUSINESS WIRE)–Pelvalon, manufacturer of the recently FDA-approved Eclipse™ System, today announced results from the original proof-of-concept study that explored the first-ever vaginal insert to treat loss of bowel control. This first-in-woman study provided the first demonstration of the key design principles of Eclipse: that a low-risk vaginal insert can effectively and comfortably control the bowel.
More than 20 million U.S. women suffer from an inability to control bowl movements, a condition that can be caused by pregnancy, childbirth, irritable bowel syndrome, or nerve or muscle damage in the pelvic region. The average age of onset is 51, and many women suffer in silence and restrict daily activities because of the stigma around the condition.
The Eclipse System, which was approved by the U.S. Food and Drug Administration (FDA) in February 2015, includes a vaginal insert 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, protecting against unwanted stool passage. Women can remove the insert at any time. The clinically proven Eclipse System, also studied in a later pivotal trial, offers women a clinically proven low-risk, non-surgical treatment option for immediate bowel control.
This first-in-woman study demonstrated for the first time that the Eclipse insert showed objective evidence of occluding the rectum and, importantly, was well-tolerated and comfortable for the women who wore it. No adverse events were reported. Thirteen women ages 40 to 90 participated in the study.
Results from the single-center, prospective, open-label clinical study were presented last week at the Society of Gynecologic Surgeons (SGS) annual meeting in Orlando, Florida.
“This study was an important proof-of-concept for the Eclipse System, demonstrating that the device could achieve its goal of comfortable rectal occlusion,” said Eric R. Sokol, M.D. Co-Chief of Urogynecology and Pelvic Reconstructive Surgery and Associate Professor at Stanford University School of Medicine. Dr. Sokol was the principal investigator for the study and presented the results at the SGS meeting. “This early feasibility work shaped the clinical development of Eclipse, which is now a breakthrough treatment in the United States for women suffering from this devastating condition.”
The study led to design improvements to increase comfort and ease-of-use of the Eclipse System, and provided rationale for additional studies demonstrating treatment effect and patient acceptance, including LIFE, the pivotal phase III study of Eclipse, which demonstrated safety and effectiveness in treating women with loss of bowel control.
“It is exciting to present the first-ever demonstration of control of the bowel with a vaginal insert. This study served as a launchpad for Pelvalon’s rigorous clinical research program,” said Miles Rosen, CEO of Pelvalon. “We are grateful to Dr. Eric Sokol, his Stanford University team, and especially to the study participants whose experiences informed the development of a product with the potential to help millions of women.”
About Fecal Incontinence
Fecal incontinence (FI), also known as Accidental Bowel Leakage (ABL), or the inability to control bowel movements, is a common problem, with more than 20 million U.S. women suffering from the condition. Women who have experienced pregnancy, childbirth, irritable bowel syndrome, or nerve or muscle damage in the pelvic region are at particular risk for bowel control problems. Many suffer in silence, fearing accidents and restricting daily activities, because of the stigma around the condition.
About the Eclipse System
The innovative Eclipse System is intended to offer women suffering from loss of bowel control a non-invasive and non-surgical treatment option. The device includes a vaginal insert placed in the same location as a tampon, and a 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.
Eclipse was studied in a pivotal study, LIFE, which 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.
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.