BlueWind Medical shared two-year data from the OASIS pivotal study of its implantable tibial neuromodulation (iTNM) system. Park City, Utah-based BlueWind said investigators presented data at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week 2024 in Washington, D.C., and the International Continence Society (ICS) 2024 Annual Meeting in Madrid.
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Data came from a study of Revi, an iTNM device implanted near the ankle during a single outpatient procedure. Patients initiate Revi therapy at their convenience by placing a lightweight, wireless wearable around their ankle once daily. This provides stimulation to the posterior tibial nerve, offering relief from urgency urinary incontinence (UUI) symptoms.
Findings demonstrated sustained efficacy and safety for iTNM for treating UUI. Key highlights included high therapy satisfaction, durable efficacy and an excellent safety profile, according to a news release.
The two-year, multi-center, single-arm pivotal trial reported 97% patient satisfaction with the Revi iTNM therapy. Additionally, 80% felt “much better” or “very much better” based on the Patient Global Impression of Improvement (PGI-I).
Revi delivered consistent effectiveness in reducing UUI episodes over time. Of 97 participants who completed the 24-month assessment, 79% continued to experience significant symptom relief. BlueWind reported no serious adverse events related to the device or procedure throughout the 24 months. The study recorded one delayed surgical site-related adverse event between 12 and 24 months. That did not require device explantation, though.
Dr. Cindy Amundsen of Duke University presented results at AUGS. Amundsen said data showed sustained therapeutic benefits, favorable safety profile and high patient satisfaction for Revi.
“These findings reinforce the durability of significant response and high patient satisfaction of the Revi system, highlighting its status as the leading solution for implantable tibial neuromodulation,” said Dr. Roger Dmochowski, chief medical officer, BlueWind Medical. “As physicians increasingly become aware of Revi as an important UUI treatment option, we are excited to share these results with the global community of healthcare professionals dedicated to advancing care for incontinence.”
