BlueWind Medical Wins FDA Nod for Next-Gen Tibial Neuromod

BlueWind Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for Revi Extend, the next generation of its implantable tibial neuromodulation (ITNM) system to treat urinary urge incontinence (UUI).

The new device has an extended life of fifteen years. The Salt Lake City-based company expects to begin limited launch of Revi Extend in the U.S. in Q4 of this year.

BlueWind pioneered ITNM for UUI in 2010. Its next-generation implant builds on clinical evidence supporting Revi’s efficacy and safety and is designed to reduce the long-term treatment burden associated with managing the chronic condition.

The Revi system provides personalized therapy that adapts to changing UUI symptoms while allowing patients to control their treatment. At three years, 79% of patients achieved at least a 50% reduction in UUI episodes, and 63% achieved at least a 75% reduction.

Patient satisfaction remained high, with 95% reporting therapeutic satisfaction through three years. No device- or procedure-related serious adverse events were reported during that period. The system is implanted through a single minimally invasive procedure under local anesthesia and doesn’t require a trial phase.

“FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians,” said Kerry Nelson, CEO 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.”

Earlier this week, the company closed $47.8 million in financing through a combination of equity and debt. The money will go toward commercialization efforts for the Revi system.