FDA approved an investigational device exemption for NeuWire Medical's stroke rehabilitation trial. The Dallas company announced the approval on October 5.
STROKE-REWIRE is prospective, multicenter, randomized and sham controlled. It will enroll up to 135 patients who have chronic ischemic stroke with upper limb dysfunction, at up to 12 US clinical centers. The primary endpoint is the change in Fugl-Meyer Assessment Upper Extremity score after 18 in-clinic rehabilitation sessions. Participants are followed for two years. Enrollment is expected to begin in the first half of 2027.
The ReWire system is a wireless implant that runs without a battery. It watches limb function during therapy and fires the vagus nerve the moment a patient completes a movement correctly, pairing the stimulation with the motion. Timing is the whole mechanism, so a sham arm is the right control and the likeliest place the label gets decided.
An IDE authorizes clinical investigation only. The device is not approved for sale and its safety and effectiveness are not established.