The Food and Drug Administration (FDA) has cleared the leva® Pelvic Health System for the first-line treatment of chronic fecal incontinence (>3 months uncontrolled passage of feces) in women. Previously, the device had been approved for use in the treatment of stress, mixed, and mild to moderate urge incontinence in women.

The leva® Pelvic Health System is a noninvasive digital therapeutic intended for the purpose of rehabilitation and training of weak pelvic floor muscles. It allows patients to monitor their progress during pelvic floor muscle training by wirelessly transmitting real-time performance data through a dedicated mobile application.

The system includes a vaginal wand embedded with motion sensors, connector, and transmitter box. Once the leva wand is inserted into the vagina, patients can open the Ieva App and begin training. Each training session can be completed in 2½ minutes twice daily for a total of less than 5 minutes a day.

The FDA clearance was based on data from a single-arm, open-label, 10-week pilot study that included 29 women with fecal incontinence (ClinicalTrials.gov Identifier: NCT04027335). Findings showed that use of the leva Pelvic Health System resulted in significant improvement in the severity of fecal incontinence symptoms, as well as in quality of life, among the 27 women with evaluable data.

“We’re gratified that the FDA has cleared this new indication for the leva Pelvic Health System as we now have a tremendous opportunity to treat a condition that’s been cloaked in silence for too long,” said Renovia’s CEO Eileen Maus. “leva enables discreet, at-home, nonsurgical, drug-free symptom relief, which we believe positions it to dramatically improve women’s access to improved first-line care.”

The Ieva Pelvic Health System is available by prescription only and is compatible with both iOS and Android smartphones.

References

  1. Renovia receives FDA clearance for leva® Pelvic Health System as first-line treatment for chronic fecal incontinence. News release. Renovia Inc. Accessed July 7, 2022. https://www.prnewswire.com/news-releases/renovia-receives-fda-clearance-for-leva-pelvic-health-system-as-first-line-treatment-for-chronic-fecal-incontinence-301582151.html
  2. Ieva Pelvic Health System: Instructions for Use. Renovia; 2022. Accessed July 7, 2022. https://www.levatherapy.com/files/leva-Instructions-For-Use.pdf
  3. Weinstein MM, Pulliam SJ, Keyser L, Richter HE. Use of a motion-based digital therapeutic in women with fecal incontinence: a pilot study. Published online December 11, 2021. Neurology and Urodynamics. doi.org/10.1002/nau.24854.