BlueWind Medical earns FDA clearance for next-gen tibial neuromod system

BlueWind Medical announced today that it received FDA 510(k) clearance for Revi Extend, its next-generation implant.

The next-generation implantable tibial neuromodulation (ITNM) system for urgency urinary incontinence (UUI) features an extended life of 15 years, reinforcing the durability of Revi for UUI. The system previously featured a 10-year lifetime.

Revi is implanted near the ankle during a single outpatient procedure. Patients initiate Revi therapy at their convenience by placing a lightweight, wireless wearable around their ankle once daily. This provides stimulation to the posterior tibial nerve, offering relief from UUI. The wearable device delivers neurmodulation therapy to seamlessly support long-term symptom relief.

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