The leva Digital Therapeutic system is already approved in the US for the treatment of mild to moderate urgency UI and pelvic floor strengthening

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FDA Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia.)

Renovia has received the US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD) for its leva Digital Therapeutic System to treat chronic faecal incontinence (FI) in women.

The company is engaged in developing digital therapeutics for female pelvic floor disorders, and leva Digital Therapeutic is the company’s lead product.

The leva Digital Therapeutic system is already approved in the US for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (UI) and pelvic floor strengthening.

Available by prescription, the device combines a small FDA-approved vaginal wand with a smartphone app to provide real-time visualisation of pelvic movement.

Renovia CEO Eileen Maus said: “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.

“While the leva Digital Therapeutic is not yet FDA cleared for the treatment of faecal 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.”

FI, which is commonly referred to as accidental bowel leakage, is a progressive condition.

The involuntary loss of stool is embarrassing and, places women at increased risk for depression, shame, guilt, social isolation, and nursing home placement.

According to the company, first-line treatments for bowel leaks comprise antidiarrheal medications and rectal biofeedback devices, and.

The medications and rectal biofeedback devices are challenging to maintain, and the evidence supporting effectiveness of current devices in treating FI is limited.

The leva System offers a non-invasive, surgery- and drug-free way for women to train and strengthen their pelvic floor muscles at home and in just five minutes a day, said Renovia.

Renovia chief medical officer Samantha Pulliam said: “The consequences of untreated chronic FI are profoundly negative for women. However, it remains vastly untreated: fewer than 30% of women seek care.

“Like UI, accidental bowel leaks often result from pelvic floor damage, so it makes sense that a treatment for UI focused on pelvic floor health promises to help women suffering from FI.

“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.”