Pelvalon, a medical device company dedicated to developing innovative solutions for women suffering from loss of bowel control, announced limited U.S. commercial availability of its Eclipse™ System, following U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s next-generation device.
"With this FDA clearance for our next-generation Eclipse, we are excited to initiate the first phase of our commercial launch in select centers of excellence," said Miles Rosen, Pelvalon’s CEO and co-founder.
"We believe that this early phase of partnership with thought and practice leaders in the field of pelvic floor disorders will ensure a smooth expansion down the road."
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.
The updated Eclipse System includes a new trial insert that allows patients to easily evaluate the therapy and decide whether it works for them. The improved system also gives physicians new sizing tools to assist with customizing the fit of the insert for their patients.
"Eclipse is a non-surgical therapy offering immediate bowel control that can be used early in the treatment pathway," 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 past president of the Society for Gynecological Surgeons (SGS). "Like the first-generation device, the next-generation Eclipse is an easily tried approach that fills a gap between lifestyle changes in diet and exercise and more invasive treatments. I’m excited that this new option will soon be available to my patients."
"Eclipse has helped my life immeasurably," said Anne Ruud, who participated in a clinical study of the Eclipse system. "It’s scary to walk around without knowing if something is going to happen, but I am now back to being me – back to my walks, going out and being social. I feel excited about it and I want other women to understand that there is hope."
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).
A pivotal trial of 61 women successfully fit with the Eclipse System demonstrated effectiveness for 86 percent of women who used the insert for a month, statistically significant improvements in quality of life metrics, and an outstanding safety profile with no serious device-related adverse events.
The most common adverse event was discomfort, most frequently associated with the fitting process and typically resolved by just removing the insert. Of women who were successfully fit and completed the one-month study, 96 percent of participants found the Eclipse to be comfortable, and 98 percent reported that they would recommend it to a friend.
Eclipse will be initially available in Alabama, Illinois, and California, with additional geographies coming soon.