FDA grants breakthrough device designation to leva system for chronic fecal incontinence


The FDA has granted a breakthrough device designation to the Ieva Digital Therapeutic System for use as a first-line treatment in women with chronic fecal incontinence (FI) in women, according to Renovia, the developer of the device.1

The breakthrough device designation will expedite the development and regulatory review of this treatment system in female patients with FI. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device.

“Women with chronic fecal incontinence have few treatment options beyond drugs or surgery. For them, daily living can be stressful, lonely, and logistically challenging as they accommodate burdensome hygiene demands and a dependence on diapers and pads,” Steven Gregg, executive director of the National Association for Continence (NAFC), stated in a news release.1

“There is a tremendous unmet need for an easy, effective solution that could offer them freedom. One that women can self-direct in the privacy of their own home would be an A plus. We applaud the FDA and Renovia for offering hope for what is a desperate situation for many millions of women,” added Gregg.

Also commenting in the release, Samantha Pulliam, MD, chief medical officer at Renovia, stated, “As the prevalence of FI increases with our aging population, it’s imperative that these women have access to affordable first-line treatments. No women should have to endure the shame, emotional distress, and health consequences associated with bowel leaks if an easy, at-home treatment can exist.”

The FDA previously approved the Ieva Digital Therapeutic System for the treatment of urinary incontinence (UI) and pelvic floor strengthening in women. This new designation allows for the expansion of this device’s benefits to women who suffer from FI.

Renovia’s small vaginal probe is implanted and connected to a mobile application, producing a noninvasive method for women to strengthen their pelvic floor muscles without the need for medication or surgery. In a previous single-arm pilot study at the University of Alabama, 26 women were evaluated to test the efficacy of the Ieva Digital Therapeutic device in treating FI. Results found that 47.6% of women achieved at least a 50% reduction in their incidents of accidental bowel leakage.2

“We’re very grateful for the opportunity to continue to work closely with the FDA to improve first-line care for chronic accidental bowel leaks for as many women as possible,” Eileen Maus, CEO of Renovia, stated in the news release.1 “While the leva Digital Therapeutic is not yet FDA cleared for the treatment of fecal incontinence, we are hopeful that Breakthrough Device Designation will help expedite patient access to the leva System as a first-line treatment for a profoundly debilitating condition.”


1. Renovia receives breakthrough device designation for Ieva digital therapeutic as first-line treatment for chronic fecal incontinence. Published online October 29, 2021. Accessed November 1, 2021. https://bit.ly/2ZSy6il.

2. Study shows Ieva Digital Therapeutic improves fecal incontinence symptoms. Published online October May 25, 2021. Accessed November 1, 2021. https://bit.ly/3by33e8.

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