FDA Greenlight for Incontinence Neurostimulation Device

Image credit: BlueWind Medical

An implantable neuromodulation system designed to treat urinary incontinence has received De Novo approval from the United States’ Food and Drug Administration (FDA).

BlueWind Medical’s Revi device works to treat the symptoms of urgency urinary incontinence (UUI), or in combination with urinary urgency.

FDA approval followed BlueWind’s OASIS pivotal clinical trial, which showed the Revi system – a small, battery-free device implanted near the ankle to stimulate the posterior tibial nerve – significantly reduced UUI symptoms compared to baseline.

“The FDA granting of the de novo request for Revi is a critical milestone that underscores BlueWind Medical’s unwavering commitment to developing an innovative alternative treatment option for the millions living with this affliction,” said BlueWind Medical’s Chief Executive Officer, Dan Lemaitre in a press statement.

“As we embark on this exciting new chapter, we remain dedicated to our mission of improving the lives of the patients we serve by helping them regain control of their UUI symptoms.”

For further information, visit the BlueWind Medical website.