FDA grants Premarket Approval to Vivistim Paired VNS for chronic stroke arm weakness

MicroTransponder/Vivistim Paired VNS System

The FDA granted Premarket Approval to the Vivistim Paired VNS System, the first implantable device approved to reduce upper extremity motor deficits in chronic ischemic stroke patients. The approval was supported by the VNS-REHAB trial demonstrating that paired stimulation with intensive rehabilitation produces greater functional gains than rehabilitation alone.

• First FDA-approved implant targeting chronic post-stroke arm weakness six months or more after stroke.
• VNS-REHAB trial of 108 patients showed 5.0-point improvement on the Fugl-Meyer scale vs. 2.4 points with rehabilitation alone.
• Vagal stimulation paired with physical therapy releases neuromodulators to enhance motor learning and brain plasticity.
• Addresses 60% of stroke survivors who retain chronic arm and hand impairment without effective treatment options.