BlueWind Medical, Ltd., a leader in Implantable Tibial Neuromodulation (ITNM) and developer of the Revi® System, a patient-centric solution for urgency urinary incontinence (UUI), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Revi Extend, the next-generation implant. The newest product has an extended life of fifteen years, reinforcing Revi’s durability for the treatment of UUI. BlueWind Medical plans a limited U.S. launch of Revi Extend in the fourth quarter of 2026.

“FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians,” said Kerry Nelson, Chief Executive Officer of BlueWind Medical. “Extending implant durability coupled with our remotely enabled software advancements allows patients to receive the latest therapy innovations for fifteen years into the future.”

Since pioneering Implantable Tibial Neuromodulation (ITNM) for urgency urinary incontinence (UUI) in 2010, BlueWind has helped establish ITNM as a well-validated therapeutic option supported by a growing body of clinical evidence. The next-generation implant builds directly on Revi’s sustained efficacy, excellent safety, and exceptional patient satisfaction. It is purpose-built and designed to reduce the long-term treatment burden for patients living with a chronic condition.

The Revi System offers:

  • Personalized therapy that adapts to each person’s unique and changing UUI symptoms

  • Patient control over their therapy

  • Durable, long-term symptom relief, with 79% of patients achieving a ≥50% reduction and 63% achieving a ≥75% reduction in UUI episodes at three years1

  • Exceptional patient satisfaction, with 95% of patients reporting therapeutic satisfaction sustained through three years of treatment1

  • Excellent safety profile, with no device- or procedure-related serious adverse events reported through three years1

  • A single, minimally invasive procedure performed under local anesthesia, requiring no trial phase

1 Amundsen CL, Sutherland SE, Heesakkers JPFA, Toozs-Hobson P, Martens F, McCrery RJ, et al. Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study. Journal of Urology. 2026 April; 0(0): https://doi.org/10.1097/JU.0000000000005062

About the Revi® Extend System

Revi® Extend is an innovative Implantable Tibial Neuromodulation (ITNM) device designed for the treatment of urgency urinary incontinence (UUI) with durability of fifteen years. Implanted near the ankle in a single outpatient procedure under local anesthesia, Revi delivers targeted stimulation to the posterior tibial nerve via a lightweight, external wearable. This design offers patients a simple, durable, and effective long-term solution for UUI symptom relief and provides patients control over their own therapy. Patients activate therapy once daily at home, without the need for internal batteries or leads, avoiding complications such as lead fracture, migration, or battery depletion.

About BlueWind Medical Ltd.

BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall well-being of patients with an initial focus on those living with urgency urinary incontinence (UUI). BlueWind’s Revi® System is the first and only Implantable Tibial Neuromodulation (ITNM) device activated by a battery-operated external wearable to receive FDA clearance for the treatment of patients with UUI. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System, rather than mandating “step-therapy.” For additional information about BlueWind Medical, please visit bluewindmedical.com.

Media gallery

About The Author
Business Wire