|Eclipse System--Courtesy of Pelvalon|
Sunnyvale, CA's Pelvalon announced the launch of its vaginal insert for bowel control following November's 510(k) clearance of the device, which is easily installed by the patients, eliminating the need for surgery or an in-office procedure.
The second-generation Eclipse System is placed in the same location as a tampon or diaphragm and contains no hormones or drugs. It contains a new trial insert that enables patients to test the therapy.
The first-generation Eclipse was cleared in February 2015 via the de novo pathway for low-to-moderate risk devices, without a substantially equivalent predecessor on the market, a demonstration of the technology's innovative nature.
"Eclipse is a non-surgical therapy offering immediate bowel control that can be used early in the treatment pathway," said Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, in a statement. "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."
According to a release, in a 61-person pivotal trial, the Eclipse was effective in 86% of women who used it for a month, and produced no serious device-related adverse events.
The device must first be fit by a doctor in an office system. The insert consists of an inflatable balloon. The patient deflates the balloon using a pump when she is ready to have a bowel movement.
Pelvalon says 20 million women in the U.S. suffer from poor bowel control, also called fecal incontinence and accidental bowel leakage.
"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 Pelvalon CEO and co-founder Miles Rosen, in a statement. "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."
Eclipse will be initially available in Alabama, Illinois, and California, prior to a full-scale launch.
The device adds to the trend towards nonsurgical options for treating incontinence. Consumer products giant Kimberly-Clark ($KMB) last year expanded retail access to the Poise Impressa Bladder Supports for the treatment of urinary incontinence.
And Kickstarter-backed sexual health company Minna Life sells the kGoal, a smart kegel exercise trainer that provides women with real-time feedback about pelvic floor exercises, which also help in the recovery from incontinence.
- read the release