FDA Clears Enhanced Revi System: Expanding Urology's Toolbox for UUI

The FDA has granted 510(k) clearance to the enhanced Revi System for urgency urinary incontinence—expanding device-based options that can reduce urgency episodes and may improve patient satisfaction.

The enhanced Revi System pairs a streamlined wearable controller and preserved three-button patient controls with refined implant ergonomics to simplify perioperative handling. These updates are intended to reduce implantation complexity and accelerate programming and patient setup.

The pivotal, prospective, single-arm OASIS trial enrolled 151 women and used a ≥50% reduction in UUI episodes on a 3-day voiding diary as the primary endpoint; 79% met that responder threshold, with no serious device- or procedure-related adverse events reported through 24 months.

Implantable tibial neuromodulation provides targeted peripheral neuromodulation—less invasive than sacral neuromodulation and more durable and customizable than percutaneous tibial nerve stimulation. Unlike behavioral therapy or pharmacotherapy, it fills a device-based niche for patients who have failed conservative measures but are not ready for sacral implants. The likeliest candidates are patients with urgency-predominant incontinence who prefer a minimally invasive, programmable option and who have failed or cannot tolerate medications.

Implantation is typically performed in an outpatient procedure suite with same-day discharge. Initial activation follows wound healing, with follow-up visits at about two, six, and 12 weeks for titration and monitoring. The external wearable controller eliminates implant recharging but requires in-clinic programming and periodic device management. Device-specific training and credentialing in tibial implant placement are required before offering the therapy; practices should arrange vendor-led clinical training and establish outpatient coding and workflow pathways as the immediate next steps.