OEM News

BlueWind Medical Shares Positive Data for Revi Tibial Neuromod for UUI

95% of patients reported therapeutic satisfaction at 36 months. Therapeutic effectiveness maintained from six to 36 months.

Author Image

By: Sam Brusco

Associate Editor

Photo: BlueWind Medical website

BlueWind Medical announced three-year results from its OASIS study were presented at this year’s Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting.

The company develops implantable tibial neuromodulation (ITNM) tech, including the Revi system, a patient-centric solution for urgency urinary incontinence (UUI). Data presented confirms Revi’s sustained efficacy, safety, and patient satisfaction.

The OASIS study involved 151 adult women with an average age of 58.8 years. It evaluated Revi to treat UUI symptoms in patients with overactive bladder (OAB)-wet.

95% of patients reported therapeutic satisfaction at 36 months. Therapeutic effectiveness maintained from six to 36 months, and 79% of participants were therapy responders (≥50% reduction in UUI episodes from baseline). 63% even experienced a ≥75% reduction in UUI episodes.

Nocturia episodes decreased from 1.3 to 0.9 per day. Significant, sustained decreases were observed in both UUI episodes and large urgency-related leaks through 36 months. No device- or procedure-related serious adverse events were reported for the study’s duration.

“With the most comprehensive and longest-term data in Implantable Tibial Neuromodulation, BlueWind has set a new benchmark for durable, patient-centered therapy for UUI,” said BlueWind chief medical officer Roger Dmochowski, MD. “Revi delivers consistent, long-lasting outcomes, proving that effective, minimally invasive treatment can be both simple and transformative. These results reinforce Revi’s position as the gold standard for clinical evidence, patient satisfaction, and sustained quality-of-life improvement in urgency urinary incontinence.”

Implanted near the ankle in one outpatient procedure under local anesthesia, Revi provides targeted stimulation to the posterior tibial nerve via a lightweight, external wearable. Patients activate therapy once daily at home without needing internal batteries or leads, avoiding complications like lead fracture, migration, or battery depletion.

The company’s enhance Revi system wearable earned U.S. Food and Drug Administration (FDA) 510(k) clearance last month.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters