Search Results

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

The Revi System is an implanted tibial electrical urinary continence device that wirelessly receives power from a non-implanted external wearable unit to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of urgency incontinence, alone or in combination with urinary urgency.

The implantable device is implanted in the vicinity of the tibial neurovascular bundle. The treatment effect of the system is achieved by the implantable wireless neurostimulation component, which sends pulses to the tibial nerve when energized by the wearable unit transmitted power. The electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord. This stimulation is theorized to have the power to modulate nerve function, relieving symptoms.

The modifications reported in this 510(k) submission include introducing an updated Wearable Unit, an associated software update to support the updated Wearable Unit and related labeling. These modifications do not affect the implantable component of the Revi System or the indications for use.

N/A

Ask a specific question about this device