FDA approves stroke rehabilitation system

The FDA approved the Vivistim System, a drug-free rehabilitation system using vagus nerve stimulation for treating moderate and severe upper extremity mobility loss caused by chronic ischemic stroke.

“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,” Christopher M. Loftus, MD, acting director of the FDA’s Center for Devices and Radiological Health’s office of neurological and physical medicine devices, said in a press release. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation.”

MicroTransponder’s Vivistim Paired VNS System (Vivistim System) used in conjunction with rehabilitation therapy helps improve motor function in the hands and arms following ischemic stroke, according to the release. The system uses an implanted pulse generator to electrically stimulate the vagus nerve, which connects the brain and abdomen. The system can be used in clinical settings and at home.

The FDA granted approval based on a clinical study of 108 patients in the U.S. and the U.K., which found patients treated with the Vivistim System had more improved mobility than patients in the control group.

“Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke,” Loftus said in the release.