A stroke-recovery implant that grew out of research at the University of Texas at Dallas has cleared a major regulatory step.
NeuWire Medical said Monday that the U.S. Food and Drug Administration approved its investigational device exemption for STROKE-REWIRE, a pivotal clinical study of the company's ReWire Vagus Nerve Stimulation System. The approval lets NeuWire test the device in people who have had a chronic ischemic stroke and still have trouble using an arm or hand.
The company credited the milestone to years of work by NeuWire and the Texas Biomedical Device Center at UT Dallas.
How the device works
ReWire pairs a small wireless implant that needs no battery with sensing technology that tracks how the limb is moving. When a patient completes a successful rehabilitation movement, the system automatically delivers vagus nerve stimulation. The idea, according to NeuWire, is to reinforce the brain pathways behind that movement and help patients regain arm and hand function.
The study
STROKE-REWIRE will enroll up to 135 participants at as many as 12 clinical sites in the United States. Patients will be randomly assigned to rehabilitation paired with active stimulation or with sham stimulation. The main measure is the change in each participant's Fugl-Meyer Assessment upper extremity score, a standard gauge of arm motor impairment, after 18 rehab sessions in a clinic.
Participants will then be followed for two years, including during home use of the device.
NeuWire expects the study to start in the first half of 2027, depending on approvals by institutional review boards and how quickly sites are ready.