FDA Approves Vivistim Stroke Rehabilitation System

The FDA has approved Dallas, Tex.-based MicroTransponder’s Vivistim vagus nerve stimulation (VNS) system for rehabilitation of stroke patients.

The agency called the device "a first-of-its-kind, drug-free rehabilitation system” to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke.

The Vivistim system includes a pulse generator placed just under the skin in the patient’s chest, which generates a mild electrical pulse delivered to electrodes placed on the left side of the neck where the vagus nerve is located.