FDA Approves First-of-Its-Kind Stroke Rehabilitation System

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Dawson J, et al. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS‑REHAB): a randomised, blinded, pivotal, device trial. Lancet, 2021:397(10284), 1545.
MicroTransponder data on file.
PMA P210007.
Francisco GE, et al. Vagus nerve stimulation paired with upper‑limb rehabilitation after stroke: two‑ and three‑year follow‑up from the pilot study. Arch Phys Med Rehabil, 2023:104(8), 1180.
Dawson J, et al. Vagus nerve stimulation paired with rehabilitation for upper limb motor impairment and function after chronic ischemic stroke: subgroup analysis of the randomized, blinded, pivotal, VNS‑REHAB device trial. Neurorehabilitation and Neural Repair, 2023:37(6), 367.
Meyers EC, et al. Vagus nerve stimulation enhances stable plasticity and generalization of stroke recovery. Stroke. 2018;49(3):710.

The MicroTransponder® Vivistim® Paired VNS™ System is intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment. Do not use if you have had a bilateral or left cervical vagotomy. Risks may include, but are not limited to pain after surgery, hoarseness, bruising, swelling, coughing and throat irritation. Infection leading to explant is a risk associated with any device surgery. For full safety information, please see Instructions for Use and our Safety Information. Individual results may vary.