Renovia announced today that it won FDA 510(k) clearance for its next-generation Leva pelvic digital therapeutic for urinary incontinence (UI) in women.
The Leva system is designed to strengthen pelvic floor muscles and treat stress incontinence as well as mixed and mild-to-moderate urgency UI in women. It uses Renovia’s patented movement-based sensor and app technology to provide feedback while women perform pelvic-floor muscle exercises.
Renovia said it based its latest version of the device on mechanisms that, in its current device, have demonstrated improvement in pelvic-floor muscle performance measures, patient-reported UI symptom severity and condition-specific quality of life. A recent 60-patient randomized controlled trial compared Leva users to a control group performing traditional Kegel exercises and revealed statistically better results among the Leva users, Renovia said.
Renovia has pushed ahead with the development of its Leva system, thanks in part to a $42.3 million funding round last year.
“We are thrilled to receive FDA clearance for the next-generation Leva digital therapeutic,” Renovia co-founder, chairman & CEO Marc Beer said in a news release. “Over the past two years, the Renovia team has taken the peer-reviewed mechanism of action of the existing Leva device and completely reimagined it in a patient-centric form factor. The next-generation Leva combines our clinically established and patented technology with a new discreet form factor and a completely redesigned app interface.”
“We look forward to announcing and publishing the results of our pilot RCT (randomized controlled trial) in the coming months,” added chief medical officer Dr. Samantha Pulliam. “In the meantime, we’re using those results to finalize the design of a larger multi-center RCT that we will launch in the first half of 2020.”
