SUNNYVALE, Calif., Feb. 13, 2015 /PRNewswire/ -- Pelvalon announced today that the U.S. Food and Drug Administration (FDA) has granted the company's de novo request to market the Eclipse System, the first vaginal insert designed to provide bowel control, in the United States. Loss of bowel control, also known as fecal incontinence, is a condition that affects over 20 million women in the U.S.
"It is so exciting that a new low risk approach for treatment has proven to be so effective for women suffering from loss of bowel control, and the Eclipse System is clinically demonstrated to be exactly that," 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). "Fecal incontinence is a truly devastating condition, and many women in my practice have tried every existing treatment without success. Eclipse offers a new alternative to these women, for immediate bowel control as well as greatly restored confidence and freedom."
FDA noted in a press release that they "granted the de novo request based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device." This pivotal study, LIFE, was recently released online ahead of print by Obstetrics & Gynecology (the Green Journal).1 Results showed a significant reduction in accidental loss of stool with almost 80% of the intent-to-treat population achieving treatment success, no device-related serious adverse events, and significant improvements in reported quality of life. Women who completed the study found the insert to be comfortable, and uniformly said they would recommend it to a friend.2
"I am thrilled to see the realization of a technology born here at Stanford University," said Eric R. Sokol, MD, Co-Chief of Urogynecology and Pelvic Reconstructive Surgery and Associate Professor at Stanford University School of Medicine, who performed the First-In-Woman study of Eclipse at Stanford in 2011. "The story of Pelvalon's rapid growth from an idea in a lab to a commercially available product in less than five years is remarkable, and so important for the women whose lives will be improved by this therapy."
Miles Rosen, CEO of Pelvalon, commented, "This news from the FDA marks a crucial milestone for Pelvalon and validates the hard work put in by our team as well as our physician partners and investigators. A lot of women don't talk about losing bowel control because it is embarrassing and the existing treatment options are so limited. Now, Eclipse is a reason to start talking to your doctor."
The company plans to release the Eclipse System later in 2015. It also continues to work on product development and clinical research in pelvic health.
Over 20 million U.S. women suffer from loss of bowel control. 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 limited options for successful, non-invasive treatments.
About 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, protecting against unwanted stool passage. Women can remove the insert at any time. The clinically-proven Eclipse System offers women a low-risk, non-surgical treatment option for immediate bowel control.
Headquartered in Sunnyvale, California, privately-held Pelvalon aims to change the lives of women who suffer from bowel control problems. Founded in 2010, Pelvalon's 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.
1 Richter et al. Obstet Gynecol 2015;0:1–8. Published online ahead of print.
2 96% of women who completed the study found the insert to be comfortable, and 98% said they would recommend it to a friend.