BlueWind Medical has secured US FDA clearance for Revi Extend, a next-generation implant designed to extend the device’s durability from 10 to 15 years and strengthen its position as a long-term, minimally invasive treatment for urgency urinary incontinence (UUI).

 

The company said it plans a limited US launch 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.”

 

The clearance marks the latest step in BlueWind’s push to establish implantable tibial neuromodulation (ITNM) as a durable treatment option for UUI, a chronic condition that can significantly disrupt daily life.

 

BlueWind has been developing ITNM for UUI since 2010. The Revi System is designed to deliver targeted stimulation to the posterior tibial nerve through a lightweight external wearable, while eliminating the need for an internal battery or leads.

 

The company says Revi Extend is implanted near the ankle during a single outpatient procedure under local anesthesia. Patients activate therapy once daily at home, giving them direct control over treatment while avoiding potential complications associated with leads, including fracture and migration, as well as battery depletion.

 

The new implant builds on clinical results from the pivotal OASIS study, which BlueWind says demonstrate sustained efficacy and safety through three years.

 

According to the company, 79% of patients achieved at least a 50% reduction in UUI episodes at three years. 63% achieved at least a 75% reduction. 95% reported therapeutic satisfaction sustained through three years.

No device- or procedure-related serious adverse events were reported through three years.

 

The Revi System is also designed to personalize therapy as symptoms change and allows patients to control their treatment.

 

Unlike therapies that require a trial phase, Revi is delivered through a single minimally invasive procedure, according to BlueWind.