Pelvalon said yesterday it won FDA 510(k) for its next-generation Eclipse incontinence device designed for women suffering loss of bowel control.
Sunnyvale, Calif.-based Pelvalon’s Eclipse is designed to be vaginally inserted, with a balloon that is inflated to put pressure on the rectal wall and prevent involuntary bowel movements. The new version includes a trial insert to allow patients to evaluate the effects of the therapy before the final insert is placed by a physician, the company said.
“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. 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,” CEO Miles Rosen said in a press release.
Fecal incontinence is generally caused by damage to the muscles surrounding the anus. Because vaginal childbirth can damage anal muscles and nerves, women are twice as susceptible to the condition as men, according to the company.
“Eclipse is a non-surgical therapy offering immediate bowel control that can be used early in the treatment pathway. 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,” Dr. Holly Richter of the University of Alabama at Birmingham said in prepared remarks.
Data from a 61-patient clinical trial reported that 86% of the women experienced effective fecal control improvements, as well as statistically significant improvements in quality of life. No serious device-related adverse events were reported, though some women did report discomfort during the fitting process.
“Eclipse has helped my life immeasurably. 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,” Eclipse study participant Anne Ruud said in a prepared statement.