BlueWind Medical lands FDA clearance for UUI implant with 15-year lifespan

BlueWind plans to initiate a limited US market launch of Revi Extend in Q4 2026.

BlueWind Medical’s Revi Extend, the company’s next-generation urge urinary incontinence (UUI) treatment that extends the implant’s lifespan to 15 years, has secured US Food and Drug Administration (FDA) clearance.

The Utah-based company’s implantable tibial neuromodulation (ITNM) system gets implanted near the ankle during a single outpatient procedure, delivering targeted stimulation to the posterior tibial nerve to alleviate UUI symptoms.

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