FDA Clears In-Home intravaginal device for Stress Urinary Incontinence

According to the National Association for Incontinence, stress urinary incontinence (SUI) affects an estimated 16.6 million women in the United States. The condition often occurs because pelvic floor muscles and tissues have been weakened, preventing the urethra from closing adequately to hold urine in the bladder. Pelvital's Flyte is the only product to use an expanding area of treatment called mechanotherapy (the treatment of disease by physical or mechanical means) to treat pelvic floor muscle weakness, the primary underlying cause of female SUI.

"Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbo charges Kegel exercises, the gold standard conservative treatment for SUI. Flyte amplifies the treatment impact of Kegels so women see results much sooner; days to weeks instead of months to years," said Dale Wahlstrom, Co-Founder and Chief Executive Officer of Pelvital.