Neuromodulation Device for Urgency Urinary Incontinence Cleared
KEY TAKEAWAYS
- Revi Extend uses implantable tibial neuromodulation delivered through an ankle implant activated by an external wearable.
- The system is designed for once-daily, at-home therapy without internal batteries or leads.
- BlueWind Medical plans a limited US launch of the next-generation device in the fourth quarter of 2026.
The Food and Drug Administration (FDA) has granted 510(k) clearance to Revi Extend (BlueWind Medical, Salt Lake City, UT), a next-generation implantable tibial neuromodulation (ITNM) device for urgency urinary incontinence (UUI) with a 15-year device life. The new implant extends the durability of the Revi platform from 10 to 15 years, according to a company announcement.
Revi Extend is implanted near the ankle during a single outpatient procedure performed under local anesthesia. The system stimulates the posterior tibial nerve through a lightweight external wearable, which patients use to activate therapy once daily at home. Because the implant does not contain internal batteries or leads, the system is designed to avoid complications related to battery depletion, lead fracture, or lead migration. No trial phase is required before implantation.
What to Know About Revi
Clinical data cited by BlueWind from the pivotal OASIS study showed sustained outcomes with the Revi System through 3 years. Among treated patients, 79% achieved at least a 50% reduction in UUI episodes and 63% achieved at least a 75% reduction. Therapeutic satisfaction was reported by 95% of patients at 3 years, and no device- or procedure-related serious adverse events were reported through that time point.
Revi is an FDA-cleared ITNM system for UUI that allows clinicians to determine whether patients need to fail or be unable to tolerate more conservative treatment before receiving the device. BlueWind Medical said a limited US launch of Revi Extend is planned for the fourth quarter of 2026.
Source:
BlueWind Medical. BlueWind Medical Receives FDA 510(k) Clearance for Revi Extend Implant. Press release. Published August 5, 2026. Business Wire.