Pelvalon, a Sunnyvale, CA firm, won FDA clearance for its second generation Eclipse System for treating fecal incontinence in women. The device is inserted into the vagina, at the same spot where the tampon goes. It comes with a little pump that can connect to the insert to inflate it. Once inflated, the device pushes on the rectum to help prevent accidental discharges. When ready to go, simply deflate the Eclipse and do your thing.
The new device comes with a trial kit that allows women to evaluate the therapy before signing up for long term treatment. Additionally, there’s now a new sizing approach to help physicians match the device to the individual patient anatomy.
From the announcement:
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.1 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.
Product page: Eclipse System…