USA – The US FDA has given Renovia’s Leva pelvic health system the green light to be marketed as a first-line treatment for chronic fecal incontinence (FI) in women.

The 510(k) clearance comes less than nine months after the technology, designed for home use, was granted FDA breakthrough device status.

Leva is already cleared and being commercialized as a treatment for stress, mixed and mild-to-moderate urinary incontinence (UI) in women.

Urinary incontinence is unintentional passing of urine, which affects one in four women, particularly 75% of women above the age 65 reporting urine leakage.

Pelvic floor muscle training (PMFT), commonly known as Kegels, is the standard among noninvasive approaches for urinary incontinence.

However, 75% of women perform the exercises incorrectly by engaging wrong muscle groups or following a wrong routine. Leva is designed to help users how to preform Kegels more effectively.

The new indication will expand the market opportunity for Leva; according to Renovia, over 12 million women in the US alone suffer from chronic FI.

Leva helps women strengthen their pelvic floor muscles with the use of a small vaginal motion sensor and a smartphone app.

The user goes through five minutes of training a day, which can be done at home and at the user’s convenience.

Leva was statistically and clinically superior to Kegel exercises alone for improving symptoms of stress and stress-dominant mixed urinary incontinence.

Traditional first-line treatment for UI is lifestyle changes and medications, and is even more limited for FI.

There are other neuromodulation devices that are out on the market, including Medtronic’s InterStim and Axonics’ r-SNM and F15 systems, which stimulate the sacral nerve; and Valencia Technologies’ eCoin which stimulates the tibial nerve; among others.

Leva does not require implantation of any device and is completely noninvasive.

Superior to Kegel-alone

Leva has proved its mettle against traditional physical therapy. In April 2022, Obstetrics and Gynecology published a randomized controlled superiority study showing that Leva was statistically and clinically superior to Kegel exercises alone for improving symptoms of stress and stress-dominant mixed urinary incontinence.

Renovia CEO Eileen Maus remarked that “Leva’s popularity among women with urinary incontinence already made it a great choice for providers, particularly OB/GYNs, who are at the frontlines of women’s care.”

Clearance for FI presents “a tremendous opportunity to treat a condition that’s been cloaked in silence for too long,” she continued.

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