BlueWind Medical, developer of the Revi system for urinary urge incontinence (UUI), has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its enhanced Revi wearable. The enhanced device was designed to more effectively deliver therapy and support long-term symptom relief.

The company has pioneered and advanced implantable tibial neuromodulation (iTNM) for UUI since 2010, growing it from a concept into a well-established therapeutic option supported by a strong clinical evidence body.

The updated Revi wearable features a smarter, user-friendly interface while keeping its same three-button control. The enhancements are meant to give patients more confidence, control, and convenience in managing their UUI.

The Revi system provides personalized therapy that adapts to unique and changing UUI symptoms with adjustable, wearable control. BlueWind said 79% of patients achieve a ≥50% reduction in UUI, with 97% of patients reporting that they’re satisfied. No device- or procedure-related serious adverse events, no device migrations, and no device revision procedures have been reported.

The procedure to place Revi is minimally invasive and performed under local anesthesia, requiring no trial phase.

“We are proud to lead the next generation of technology for the treatment of urgency urinary incontinence,” said Kerry Nelson, CEO of BlueWind Medical. “BlueWind has been at the forefront of the field, pioneering implantable tibial neuromodulation for UUI. Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve. The enhanced wearable continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use. All of this helps patients achieve durable symptom relief and overall satisfaction.”

Earlier this year, the company released 24-month Quality of Life (QoL) results from the OASIS pivotal study for its iTNM system for UUI showing consistent QoL benefits.