Bluewind Medical

The Revi implant system. [Image from BlueWind Medical]BlueWind Medical announced today that a doctor treated the first patient in the RESTORE study of its Revi iTNM device.

Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, treated the first patient. The prospective, multi-center, open-label, post-market, randomized controlled trial aims to recruit 150 patients across up to 20 U.S. centers.

BlueWind designed Revi as an implantable tibial neuromodulation (iTNM) device to treat urge urinary incontinence (UUI). The Park City, Utah-based company says Revi is placed near the ankle in a single, predictable procedure under local anesthesia. A lightweight external wearable, used at the patient’s convenience, powers the system, used once or twice daily.

When activated, Revi stimulates the posterior tibial nerve to provide relief from UUI. Revi received FDA marketing authorization in August 2023.

Padron said that current UUI treatments wor…

The Revi implant system. [Image from BlueWind Medical]BlueWind Medical announced today that the FDA granted a de novo marketing request for its Revi neuromodulation system.

Park City, Utah-based BlueWind designed Revi as a tibial neuromodulation system for treating the symptoms of incontinence. It treats urgency incontinence alone or in combination with urinary urgency.

De novo approval for men and women with urge urinary incontinence (UUI) received support from BlueWind’s OASIS pivotal trial. OASIS demonstrated that Revi provided significant improvement in UUI symptom reduction compared to baseline. It also showed a favorable safety profile.

Revi, a small, battery-free device is implanted near the ankle during a single, minimally invasive outpatient procedure. When activated, Revi stimulates the posterior tibial nerve to provide relief from UUI. Users receive a lightweight, wireless wearable placed around the ankle for activation once to twice daily …