On March 1, 2022 FDA approved Valencia Technologies’ eCoin Peripheral Neurostimulator System to stimulate the tibial nerve to treat Urge Urinary Incontinence. The eCoin system delivers electrical pulses to the tibial nerve in 30-minute sessions based on a fixed schedule. A healthcare provider can adjust the level of stimulation based on each patient’s sensitivity and needs, using the remote control.
Category Archives: Tibial Nerve Stimulation
BlueWind Medical’s Revi System Tibial Neuromodulation System Approved by FDA
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.