19 Aug 2023 • The FDA has granted a de novo marketing request for the Revi System for tibial neuromodulation to treat urinary incontinence, with or without urinary urgency. This treatment is indicated for both men and women with urge urinary incontinence (UUI). The Revi implant, which is battery-free, is surgically placed near the ankle during an outpatient procedure under local anesthesia. A wireless wearable device worn around the ankle activates the implant to stimulate the posterior tibial nerve. The approval is supported by the OASIS trial involving 151 women with UUI. After 6 months, 75% of patients experienced a 50% reduction in UUI episodes, rising to 82% for those who completed a 12-month follow-up. Safety profile remained positive over 12 months, with 95% of participants satisfied and over 90% maintaining device compliance at 12 months. Source: Medpage Today | Read full story