FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence

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, BlueWind Medical announced on Thursday.

The de novo request allows for treatment of men and women with urge urinary incontinence (UUI). Clinicians should follow applicable clinical guidelines and use professional judgment to determine if the device can be used before failure or intolerance of more conservative therapy, the company said.

"UUI is a debilitating, life-altering condition that impacts every aspect of a patient's life," said Cindy L. Amundsen, MD, of Duke University Medical Center in Durham, North Carolina, in the announcement. Efficacy and safety data "support the Revi device as a new option for those living with the frustrations of UUI."

"Additionally, while patient management should be based on clinical guidelines, use of this therapy may be considered by a physician's assessment before patients fail or cannot tolerate more conservative therapy, which could make this single outpatient procedure available to a larger number of patients with UUI," she added.

The Revi implant includes a small, battery-free neuromodulator implanted near the ankle during an outpatient procedure with local anesthesia. A lightweight wireless wearable device placed around the ankle one or twice daily activates the implant to stimulate the posterior tibial nerve.

Support for the de novo grant came from the multicenter, single-arm OASIS trial, which evaluated the device in 151 women with UUI, including urinary urgency. Three-fourths of patients had at least a 50% reduction in UUI episodes after 6 months, increasing to 82% of patients who completed 12 months of follow-up. Also at 12 months, half of the patients remained 100% dry during a 3-consecutive-day assessment.

The device had a favorable safety profile over the 12-month evaluation, and 95% of study participants expressed satisfaction with the treatment. Additionally, more than 90% of patients remained compliant at 12 months with once-daily use of the device.

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