BlueWind Medical, developer of the Revi System, a solution for urgency urinary incontinence (UUI), today announced that the FDA has granted 510(k) clearance for Revi Extend, the next-generation implant.
The newest product has an extended life of 15 years, reinforcing Revi's durability for the treatment of UUI. BlueWind Medical plans a limited U.S. launch of Revi Extend in the fourth quarter of 2026.
Implanted near the ankle in a single outpatient procedure under local anesthesia, Revi delivers targeted stimulation to the posterior tibial nerve via a lightweight, external wearable. Patients activate therapy once daily at home, without the need for internal batteries or leads, avoiding complications such as lead fracture, migration, or battery depletion.
"FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians," said BlueWind CEO Kerry Nelson in a statement. "Extending implant durability coupled with our remotely enabled software advancements allows patients to receive the latest therapy innovations for fifteen years into the future.”
