The FDA announced today that it approved the MicroTransponder Vivistim paired VNS system for chronic ischemic stroke rehabilitation.
MicroTransponder designed its Vivistim System as a first-of-its-kind, drug-free rehabilitation system for treating moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation, according to an FDA news release.
Vivistim electrically stimulates the vagus nerve to reduce deficiencies in upper limb and extremity motor function and to improve patients’ ability to move their arms and hands. An implantable pulse generator is implanted just under the skin in the patient’s chest with a lead wire that leads up to electrodes placed on the left side of the neck where the vagus nerve is.
Along with the implantable components, clinician software on a laptop and a wireless transmitter are used by a healthcare provider to manage a patient’s rehabilitation through settings such as amplitude, frequency and pulse width while also recording stimulation history, movements and information about the implant.
The platform, a prescription device, may be used in both clinical and at-home settings to provide VNS. The approval came on the back of a 108-patient study across 19 clinical sites in the U.S. and United Kingdom. Measuring effectiveness through the Upper Extremity Fugl-Meyer Assessment (FMA-UE), patients receiving Vivistim treatment averaged a score increase of five points, while the control group (only receiving a very low level of VNS) averaged an increase of 2.4 points.
Additionally, 47.2% in the treatment group improved by six or more points at 90 days post-therapy, while just 23.6% did so in the control group.
“People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function,” acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices Dr. Christopher M. Loftus said in the release. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation. Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”