FDA Clears BlueWind's Revi Extend Bladder Implant

FDA granted 510(k) clearance on 5 August 2026 to Revi Extend, BlueWind Medical's next-generation implant for urgency urinary incontinence, extending the device's working life to 15 years and leaning on three-year outcomes data from the company's pivotal OASIS trial. BlueWind plans a limited US launch in the fourth quarter.

What changed from the prior-generation implant

Revi Extend is the implanted half of BlueWind's Revi System, which pairs a small implant near the ankle with an external wearable to deliver tibial neuromodulation — targeted electrical stimulation of the posterior tibial nerve intended to restore signaling between bladder and brain in patients with urgency urinary incontinence. The clearance's headline change is durability: Revi Extend is built for 15 years of service, extending the implant life of the prior-generation device and, in principle, reducing how often a patient needs a replacement procedure over a treatment course that may otherwise run for decades.

The data behind the clearance

BlueWind supported the submission with three-year follow-up from its pivotal OASIS trial, published in The Journal of Urology. Among evaluable participants, 79% achieved at least a 50% reduction in UUI episodes and 63% achieved at least a 75% reduction, with 95% reporting sustained therapeutic satisfaction through three years of follow-up. The company and reporting outlets covering the clearance both note no device- or procedure-related serious adverse events in that follow-up window. For a device intended to stay implanted for up to 15 years, a three-year durability read is a meaningful but partial answer — it establishes the treatment holds up well past the first year, not that it holds up for the full stated device life.

Two Revi clearances, not one

This clearance is easy to conflate with an earlier one: BlueWind received a separate 510(k) clearance on 16 December 2025, K252391, for an enhanced Revi wearable component supporting long-term UUI treatment. That clearance covered the external, non-implanted part of the system. Revi Extend, cleared eight months later, is the implant itself, with the 15-year durability claim attached. Practitioners tracking BlueWind's regulatory file should treat the two as what they are — sequential clearances for different components of the same therapy — rather than a single expanded label.