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.
“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.
For more information visit flytetherapy.com.
- Pelvital announces FDA clearance of Flyte™, in-home pelvic floor muscle treatment for stress urinary incontinence. https://www.businesswire.com/news/home/20200820005151/en/Pelvital-Announces-FDA-Clearance-Flyte%E2%84%A2-In-Home-Pelvic. Accessed August 20, 2020.
- About Flyte. https://flytetherapy.com/about-flyte/. Accessed August 20, 2020.