BlueWind Medical’s Revi for Urinary Urge Incontinence Nabs De Novo Nod

BlueWind Medical has been granted De Novo approval from the U.S. Food and Drug Administration for its Revi system, a tibial neuromodulation therapy to treat symptoms of urgency incontinence alone or in combination with urinary urgency. The De Novo grant is for men and women with urinary urge incontinence (UUI) and was based on data from the OASIS pivotal trial.
 
The Revi implant is a small, battery-free device implanted near the ankle in a single, minimally invasive outpatient procedure under local anesthesia. When activated, it stimulates the posterior tibial nerve to offer UUI relief. To activate, a lightweight, wireless wearable is placed around the ankle once to twice per day for stimulation at the patient’s convenience.
 
Revi’s battery-free design allows the implant to measure 3 cm in length and 3 mm in diabeter, meaning future surgery for battery depletion, lead fracture, or lead migration shouldn’t be necessary, according to the company.
 
“UUI is a debilitating, life-altering condition that impacts every aspect of a patient’s life,” Cindy L. Amundsen, MD, Roy T. Parker Distinguished Professor of Obstetrics and Gynecology, Division of Urogynecology, Professor of Urology at Duke University School of Medicine who is an investigator for the OASIS clinical trial, told the press. “The OASIS safety and efficacy data support the Revi device as a new option for those living with the frustrations of UUI. Additionally, while patient management should be based on clinical guidelines, use of this therapy may be considered by a physician’s assessment before patients fail or cannot tolerate more conservative therapy, which could make this single outpatient procedure available to a larger number of patients with UUI.”
 
The 151-woman OASIS clinical study demonstrated that 76.4% of subjects implanted achieved at least 50% reduction in urge incontinence episodes at six months. At 12 months, 82% of patients completing the study achieved at lease 50% reduction in urge incontinence episodes.
 
In patients who completed the study, the percentage who experienced a ≥75% reduction in UUI symptoms increased from 52.1% at 6 months (75/144) to 66.9% (93/139) at 12 months. In addition, subjects who completed the study through 12 months were compliant with once-daily treatments 91.6% of the time.
 
“The FDA granting of the De Novo request for Revi is a critical milestone that underscores BlueWind Medical’s unwavering commitment to developing an innovative alternative treatment option for the millions living with this affliction,” said Dan Lemaitre, CEO of BlueWind Medical. “As we embark on this exciting new chapter, we remain dedicated to our mission of improving the lives of the patients we serve by helping them regain control of their UUI symptoms.”