The Food and Drug Administration (FDA) has granted clearance for Flyte™ (Pelvital), a noninvasive, intravaginal home-use device intended for the treatment of stress urinary incontinence (SUI) in patients aged ≥21 years.

Flyte is an in-home treatment designed to strengthen and treat weakened pelvic floor muscles to reduce bladder leaks and restore continence. The Flyte wand is placed in the vagina where it delivers a series of mechanical pulses while the individual contracts their pelvic floor muscles for 5 minutes per day for 6 weeks.

The clearance for Flyte was based on efficacy and safety data from 2 clinical trials conducted in Norway and the US; these included more than 200 adult patients with SUI. In the US study (n=119), following 12 weeks of treatment with Flyte, 91% of patients were considered responders, defined as those having ≥10% reduction in leakage. Additionally, the mean reduction in pad weight, which measured urine lost and captured in incontinence pads, was reported to be 21.4 grams.

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“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 CEO of Pelvital.

The product will be commercially available to consumers in August 2020.

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  1. Pelvital announces FDA clearance of Flyte™, in-home pelvic floor muscle treatment for stress urinary incontinence. Accessed August 20, 2020. 
  2. About Flyte. Accessed August 20, 2020.