ESOC 2021 | First of its kind vagus nerve stimulation device approved for upper extremity deficits after stroke

In August 2021, the MicroTransponder Vivistim Paired Vagus Nerve Stimulation (VNS) System was approved by the FDA for the treatment of moderate to severe upper extremity motor deficits associated with chronic ischemic stroke. Seth Hays, PhD, The University of Texas at Dallas, Dallas, TX, discusses the clinical trial data that led to the approval of the Vivistim System, a first of its kind, drug-free rehabilitation device. The pivotal Phase III double-blinded VNS-REHAB study (NCT03131960), randomized over 100 patients 1:1 to receive active VNS or sham stimulation, paired with standardized rehabilitation. The VNS group showed significantly better recovery, shown by a clinically meaningful response on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score in 47% of participants compared to 24% in the control arm. The safety and efficacy findings in this study led to the recent FDA approval. This interview took place at the European Stroke Organisation Conference (ESOC), 2021.