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# BlueWind De Novo for Incontinence Device
- URL: https://www.fdaweb.com/bluewind-de-novo-for-incontinence-device/
- Published: 2023-08-17T12:00:00.000Z
- Updated: 2026-09-14T18:51:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155124

FDA has granted BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms of urgency incontinence alone or in combination with urinary urgency. The authorization was based on results from the OASIS pivotal trial, in which the device demonstrated a “statistically significant improvement with 76.4% of subjects implanted achieving at least a 50% reduction in urge incontinence episodes at 6 months (p<.0001),” BlueWind says. “At 12 months, 82.0% (114/139) of subjects completing the study achieved at least a 50% reduction in urge incontinence episodes.”

The device is implanted near the ankle during an outpatient procedure, according to the company. “When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI \[urge urinary incontinence\],” it says. “For activation, a lightweight wireless wearable is placed around the ankle once to twice daily to provide stimulation at the patient’s convenience.”