Pelvital announced that it received FDA clearance for its Flyte device for treating those with stress urinary incontinence.
Minneapolis-based Pelvital touts Flyte as a first-of-its-kind, non-invasive, intravaginal home-use device designed to strengthen the pelvic floor muscles, which can help women with stress urinary incontinence, according to a news release.
Physicians at the Arctic University of Norway and other researchers in related fields originally developed Flyte before two clinical trials took place in Norway and the U.S., treating 200 patients and observing that most were dry or near dry after two to 12 weeks of treatment.
The company said Flyte is the only product to use an expanding area of treatment called mechanotherapy to treat pelvic floor muscle weakness, and the device will be made available to consumers in the U.S. sometime this month.
“Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbocharges Kegel exercises, the gold standard conservative treatment for SUI,” Pelvital co-founder & CEO Dale Wahlstrom said in the release. “Flyte amplifies the treatment impact of Kegels so women see results much sooner; days to weeks instead of months to years.”