Evidence from Pelvalon’s Eclipse System Early Experience Now Published in BMJ Innovations

Pelvalon Announces Publication in BMJ Innovations of Peer-Reviewed Research

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Pelvalon, manufacturer of the Eclipse™ System for non-surgical treatment of female loss of bowel control, today announced the publication in BMJ Innovations of peer-reviewed research from the original proof-of-concept study. This first-in-woman study provided the initial demonstration of the key design principles of Eclipse: that a non-surgical vaginal insert can effectively and comfortably control the bowel.

Eric R. Sokol, M.D., Co-Director of Urogynecology and Pelvic Reconstructive Surgery and Associate Professor at Stanford University School of Medicine, was the principal investigator for this early study of the first vaginal insert for bowel control. “This feasibility work was an important proof-of-concept for the Eclipse System, demonstrating that a vaginal insert could successfully occlude the rectum and, importantly, was well tolerated and comfortable for the women who wore it,” said Dr. Sokol. “These findings lead to clinical development of Eclipse, which is now helping women across the United States suffering from this embarrassing condition.”

The Eclipse System is the first vaginal insert designed to provide immediate bowel control. Placed in the same location as a tampon or a diaphragm, the insert contains no hormones or drugs and can be removed at any time. This first-in-women study was conducted at Stanford Hospital, and evaluated the insert in thirteen women aged 40-90. The pivotal trial results of the broader LIFE study supported the FDA clearance of the Eclipse System and were published in Obstetrics & Gynecology in February 2015.

“The Eclipse System has roots in the Stanford Biodesign program, and a partnership with the Coulter Foundation allowed this early research to be conducted,” said Miles Rosen, CEO of Pelvalon. “I’d like to thank Dr. Sokol for his leadership in this original work. Upon publication of this data, we are gratified to look backward over the past 7 years at all that has been achieved since these first women evaluated Eclipse.”

BMJ Innovations highlights the latest medical devices, technologies, processes and systems that improve patient care, focusing on clinical innovation.

Loss of bowel control, sometimes called accidental bowel leakage (ABL) or fecal incontinence (FI) is a debilitating condition that can be caused by pregnancy, childbirth, nerve or muscle damage in the pelvic region, and gastrointestinal disorders such as irritable bowel syndrome (IBS). Sometimes women will feel a strong urge to have a bowel movement; other times, leakage can occur without warning. Typical first-line treatments include dietary changes, exercise and medications. If the issue persists, patients may need to move on to more invasive and costly treatments, such as surgery, surgical implants, or injections. The Eclipse System provides a new, non-surgical option for these women.

About the Eclipse System
Pelvalon’s Eclipse System is placed in the same location as a tampon or a diaphragm, and can be removed at any time. A hand-held pump is used to inflate and deflate a balloon on the insert. The balloon is designed to occlude the rectum to protect against unwanted stool passage. The insert does not contain drugs or hormones. In a clinical study of the Eclipse System, no serious device-related adverse events were observed. The most common adverse event was pelvic discomfort. The first generation of the system was cleared by the FDA for the treatment of fecal incontinence in adult women.

About Pelvalon
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.

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Media Contact:
Amy Cramer