Image Credit: Bluewind Medical
On August 17, 2023, the FDA authorized marketing for BlueWind Medical’s Revi System, a Tibial Neuromodulation System intended for use in the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. The device consists of an active implantable wireless neurostimulation component intended to be placed in the vicinity of the tibial neurovascular bundle for peripheral nerve stimulation. Since the implant has no battery, the wearable unit transmits energy via magnetic coupling to the implant, which consequently generates electrical pulses stimulating the tibial nerve. These electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord, relieving symptoms of urinary incontinence alone or in combination with urinary urgency.
