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), has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Revi Extend. The company says it is planning a limited U.S. launch of Revi Extend in the fourth quarter of 2026.
Kerry Nelson, Chief Executive Officer of BlueWind Medical said: “FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians. 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 says it has helped establish ITNM as a well-validated therapeutic option supported by a growing body of clinical evidence. The new implant is purpose-built and designed to reduce the long-term treatment burden for patients living with a chronic condition according to the company.
BlueWind says the Revi System offers personalised therapy that adapts to each person’s unique and changing UUI symptoms; patient control over their therapy; durable, long-term symptom relief; 95% of patients reporting therapeutic satisfaction sustained through three years of treatment; ‘excellent’ safety profile, no device or procedure-related serious adverse events reported through three years; and a single minimally invasive procedure performed under local anaesthesia, requiring no trial phase.
