BlueWind Medical Revi neuromodulation implant
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 work for some people, “but not most.” He highlighted the need for a more patient-centric and minimally invasive option, like Revi. According to Padron, the RESTORE study should help advance treatment options for people who suffer from UUI.

“This is a great day in our collective journey to bring more convenient, comfortable, and patient-centric treatment options to people suffering from the debilitating symptoms of urge urinary incontinence,” said Dan Lemaitre, CEO of BlueWind Medical. “We are so grateful to Dr. Padron for treating the first patient in this critical research effort to help transform the treatment paradigm for UUI.”