SUNNYVALE, Calif.–(BUSINESS WIRE)–Pelvalon, a medical device company dedicated to developing innovative solutions for women suffering from loss of bowel control, today announced publication of a peer-reviewed analysis of the company’s Eclipse™ System in The Journal of Medical Devices: Evidence and Research.
“A novel concept, the Eclipse System offers a noninvasive option for women suffering from loss of bowel control. Multiple feasibility studies and a pivotal study have demonstrated the potential for the insert to offer immediate effectiveness with minimal risk and a positive impact on quality of life.”
Eric R. Sokol, M.D., co-chief of Urogynecology and Pelvic Reconstructive Surgery and associate professor at Stanford University School of Medicine, is the author of the review, titled “Management of fecal incontinence – focus on a vaginal insert for bowel control.”
In his analysis, Dr. Sokol discusses the limitations of existing therapies for treating accidental bowel leakage (ABL), and the unmet need for effective and minimally invasive treatments. In addition, Dr. Sokol provides an overview of the design evolution of the Eclipse System, data from multiple studies of Eclipse, including feasibility studies and the results of the LIFE clinical trial, which demonstrated the device’s safety and effectiveness.
“ABL is a devastating condition for women with few effective options,” said Dr. Sokol. “A novel concept, the Eclipse System offers a noninvasive option for women suffering from loss of bowel control. Multiple feasibility studies and a pivotal study have demonstrated the potential for the insert to offer immediate effectiveness with minimal risk and a positive impact on quality of life.”
“We are grateful for Dr. Sokol’s thorough review of the Eclipse System,” said Miles Rosen, co-founder and CEO of Pelvalon. “Given that Eclipse is the first device of its kind, we have placed a strong emphasis on clinical research and development, and Dr. Sokol’s analysis neatly describes the full body of evidence.”
More than 20 million women in the U.S. suffer from loss of bowel control, sometimes called accidental bowel leakage (ABL) or fecal incontinence (FI). This debilitating condition 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.
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. In a clinical trial of women who used the insert for one month, Eclipse was effective in 86% of those successfully fit with the insert. The most common adverse event was discomfort, most frequently associated with the fitting process and typically resolved by just removing the insert. At the end of the study, 96% of participants successfully fit with the insert found the Eclipse to be comfortable, and 98% reported that they would recommend it to a friend.
Pelvalon recently announced limited U.S. commercial availability of the system following U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s next-generation device.
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.