Park City, Utah-based BlueWind designed Revi as a tibial neuromodulation system for treating the symptoms of incontinence. It treats urgency incontinence alone or in combination with urinary urgency.
De novo approval for men and women with urge urinary incontinence (UUI) received support from BlueWind’s OASIS pivotal trial. OASIS demonstrated that Revi provided significant improvement in UUI symptom reduction compared to baseline. It also showed a favorable safety profile.
Revi, a small, battery-free device is implanted near the ankle during a single, minimally invasive outpatient procedure. When activated, Revi stimulates the posterior tibial nerve to provide relief from UUI. Users receive a lightweight, wireless wearable placed around the ankle for activation once to twice daily for convenience.
BlueWind says the patient-centric, battery-free design allows for the miniaturization of Revi to measure 3 cm in length and 3 mm in diameter. This could eliminate the need for future surgery due to battery depletion, lead fracture or lead migration.
“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.”
More about the BlueWind OASIS trial that supported Revi’s approval
OASIS, a prospective, multicenter, single-arm, open-label study evaluated a total of 151 women.
The trial met its primary endpoint, demonstrating a statistically significant improvement in urge incontinence episodes at six months. Of implanted subjects, 76.4% achieved at least a 50% reduction in episodes. At 12 months, 82% (114/139) completing the study achieved at least a 50% episode reduction.
Additionally, at 12 months, 49.6% (69/139) remained 100% dry during an assessment over three consecutive days. BlueWind reported no serious procedure- or device-related adverse events. All events that occurred were adjudicated by the study’s clinical event committee as either mild or moderate.
“UUI is a debilitating, life-altering condition that impacts every aspect of a patient’s life,” said Dr. Cindy L. Amundsen, 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. “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.”
