Three-year efficacy and safety of Revi® Implantable Tibial Neuromodulation from the pivotal OASIS Study.

Abstract

Revi® is a novel implantable tibial neuromodulation (iTNM) system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (UUI). The Revi System (manufactured by BlueWind Medical) is the first FDA-cleared implantable neuromodulation device that can be used in traditionally non-refractory patients. Three-year follow-up results from the pivotal FDA-approval trial, the OASIS Study, are presented. The Revi System was implanted in 151 women. The primary efficacy and safety endpoints were assessed at 6 and 12 months, respectively; thereafter, participants were consented to extend follow-up to 3 years for assessments of long-term treatment durability and safety. Ninety-three percent (140/151) completed the 12-month study and 85% (119/140) met screening criteria and consented to the 36-month extension study. Ninety participants (76%, (90/119) completed the 36-month assessment and 79% (71/90) were therapy responders (≥ 50% reduction in UUI episodes, demonstrated on a 3-day voiding diary). Sustained therapeutic responses were reported, with durable effectiveness between 6 and 36 months (response rates of 78% and 79%, respectively).Notably, 95% (83/87) reported therapeutic satisfaction and 82% (74/90) reported feeling "much better" or "very much better" based on the Patient Global Impression of Improvement (PGI-I) scale. No device- or procedure- related serious adverse events were reported through 36 months. In women with UUI, Revi - an iTNM system powered by a patient-controlled, external wearable ankle device - showed meaningful and durable efficacy, high patient satisfaction, and an excellent safety profile through 3 years.