BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the creator of the Revi® System, has announced the presentation of new two-year data from its OASIS pivotal study. These findings were shared at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders Week 2024 in Washington, D.C., from October 22-25, and at the International Continence Society (ICS) 2024 Annual Meeting in Madrid, from October 23-25.
Findings from a two-year, multi-center, single-arm pivotal trial have demonstrated the sustained efficacy and safety of implantable Tibial NeuroModulation (iTNM) for treating urgency urinary incontinence (UUI). Key highlights include:
- High Therapy Satisfaction: After 24 months, 97% of participants expressed satisfaction with Revi Therapy, and 80% reported feeling “much better” or “very much better,” as measured by the Patient Global Impression of Improvement (PGI-I).
- Durable Efficacy: The therapy consistently reduced UUI episodes, with 79% of the 97 participants who completed the assessment experiencing significant symptom relief throughout the study.
- Excellent Safety Profile: There were no serious adverse events related to the device or procedure over the 24-month period. The only recorded adverse event was a delayed surgical site issue that occurred between 12 and 24 months and did not require device removal.
Dr. Cindy Amundsen, from Duke University and a trial investigator who presented at AUGS, stated, “These data indicate that the benefits of the Revi System are not only sustained over time but also lead to high patient satisfaction and a strong safety profile, marking a significant advancement in treating urgency urinary incontinence.”
The Revi System, a Class II device, is a cutting-edge iTNM solution implanted near the ankle during a single outpatient procedure under local anesthesia. It has a lower reintervention rate compared to other UUI therapies, which often require intervention due to issues like lead fracture or battery depletion. Patients can conveniently initiate therapy by wearing a lightweight, wireless device around their ankle once daily to stimulate the posterior tibial nerve, providing relief from UUI symptoms.
Dr. Roger Dmochowski, Chief Medical Officer at BlueWind Medical, remarked, “These findings underscore the durability of the Revi system’s response and high patient satisfaction, establishing it as the leading solution for implantable tibial neuromodulation. As more physicians recognize Revi as a vital UUI treatment option, we are eager to share these results with healthcare professionals dedicated to improving incontinence care.”
For more information about BlueWind Medical and the Revi System, visit bluewindmedical.com.
About BlueWind Medical Ltd.
BlueWind Medical is innovating in the field of neuromodulation therapy, focusing on patient-centered technology for disease treatment. The company aims to enhance the quality of life for patients, particularly those with urge urinary incontinence (UUI). The Revi System is the first and only implantable tibial neuromodulation device activated by an external battery-operated wearable that has received FDA marketing authorization for UUI patients. Unlike other neuromodulation therapies, Revi allows physicians to decide whether a patient should move on to this option without requiring a “step-therapy” approach.
