Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study

Revi is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence. The Revi System (manufactured by BlueWind Medical) is the first FDA-cleared implantable neuromodulation device that can be used in traditionally nonrefractory 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 end points 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 urgency urinary incontinence 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 scale. No device-related or procedure-related serious adverse events were reported through 36 months.

In women with urgency urinary incontinence, Revi-an implantable tibial neuromodulation 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.