The next-generation implantable tibial neuromodulation (ITNM) system for urgency urinary incontinence (UUI) features an extended life of 15 years, reinforcing the durability of Revi for UUI. The system previously featured a 10-year lifetime.
Revi is implanted near the ankle during a single outpatient procedure. Patients initiate Revi therapy at their convenience by placing a lightweight, wireless wearable around their ankle once daily. This provides stimulation to the posterior tibial nerve, offering relief from UUI. The wearable device delivers neurmodulation therapy to seamlessly support long-term symptom relief.
BlueWind won FDA clearance for an enhanced version of Revi at the end of 2025. It also brought in nearly $50 million to support its Revi rollout earlier this year.
The company previously labeled Revi the first and only FDA-cleared iTNM system activated by an external wireless wearable for patients with UUI. Medtronic joined the market with FDA approval of its Altaviva tibial neuromodulation system for UUI in September 2025. Altaviva activation occurs before a patient goes home, with no daily intervention or manual adjustments required.
“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.”
