The FDA granted 510(k) clearance to Revi Extend, an updated implantable tibial neuromodulation system, on August 5, 2026, for the treatment of urgency urinary incontinence (UUI). This system features an extended device life span of 15 years.
BlueWind Medical plans a limited US launch in the fourth quarter of 2026. The clearance was supported by 3-year data from the OASIS trial published in The Journal of Urology.
Study Results
The OASIS study was a prospective, multicenter, single-arm, open-label trial evaluating the efficacy and safety of the Revi System in women with UUI. Inclusion required at least 9 UUI episodes on a 7-day bladder diary.
Of 151 implanted participants, 90 completed the 36-month assessment. Therapy response was achieved in 79% of participants at 36 months, whereas 63% achieved a 75% or greater reduction.
Participants reported a mean of 1.2 UUI leaks per day at 36 months vs 4.8 per day at baseline. Nocturia episodes decreased from 1.28 per day at baseline to 0.88 per day at 36 months.
Patient Satisfaction and Quality of Life
At 36 months, 95% of participants who completed satisfaction questionnaires reported being satisfied with the therapy, and 82% reported feeling “much better” to “very much better” on the Patient Global Impression of Improvement scale.
A total of 98% of participants reported willingness to continue treatment. Clinically meaningful improvements exceeding the minimal important difference threshold were observed across all domains of the Overactive Bladder Questionnaire through 36 months.
The Revi System is performed as a single minimally invasive procedure under local anesthesia, requiring no formal trial phase before implantation. It uses an external, battery-powered wearable ankle controller, eliminating the need for future battery-replacement surgery.
No device- or procedure-related serious adverse events were reported through 36 months. However, some participants experienced device-related adverse events, such as pain or stimulation-related discomfort.
The study had limitations, including a lack of randomization and blinding. The extended study was initiated after some participants had already completed the 12-month visit, reducing the number of participants available at 3 years.
The study’s results have been published in The Journal of Urology, providing further insight into the efficacy and safety of the Revi System. BlueWind Medical’s receipt of FDA 510(k) clearance for the Revi Extend implant marks a significant milestone in the development of this treatment option for urinary incontinence.
