BlueWind Medical Wins FDA Clearance for 15-Year Tibial Neuromodulation Implant

Summary

BlueWind Medical received FDA 510(k) clearance for Revi Extend, a next-generation version of its implantable tibial neuromodulation device for urgency urinary incontinence, extending the device's functional life from 10 to 15 years. The implant sits near the ankle and pairs with an external wearable to stimulate the posterior tibial nerve without internal batteries or leads. Three-year data from the current Revi System's pivotal OASIS study found 79% of patients achieved at least a 50% reduction in incontinence episodes, with no device- or procedure-related serious adverse events. A limited US launch of Revi Extend is planned for the fourth quarter of 2026.