USA – Vagal nerve stimulator for stroke rehab nabs FDA nod

The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent pathway.

The vagal nerve stimulation (VNS) system will be marketed by MicroTransponder as the Vivistim Paired VNS System. The device enters the market through FDA’s premarket approval pathway after receiving breakthrough device designation.

« 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, » said Christopher M. Loftus, acting director of the Office of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. « 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, » added Loftus in the press announcement of the approval…