Innovative Stroke Rehabilitation System Vivistim Given FDA Approval

Ischemic stroke patients have scored a victory with the FDA’s approval and Breakthrough Device designation of the MicroTransponder Vivistim Paired VNS System. This drugless rehabilitation system assists with the treatment of upper-extremity motor deficits by using vagus nerve stimulation.

By carefully prodding the vagus nerve with electricity, Vivistim can mitigate deficiencies in the motor function of extremities—particularly upper limbs. The implanted technology is paired with clinician software and a wireless transmitter. With Vivistim’s software, providers can manage patient rehabilitation, fine-tune the implantable pulse generator’s settings via the transmitter, and cross-reference stimulation history.

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The FDA’s evaluation process included a clinical study of 108 patients in 19 clinical sites in the U.S and the U.K. A general improvement in motor function from baseline over a six-week period was considered tangible progress.

Patients had to partake in over 300 physical therapy exercises for 90 minutes per day, three times a week. The control group was exposed to limited instances of VNS treatment near the beginning of the study, while treatment group patients received the recommended amount. Treatment group patients had a score improvement twice as high as those in the control group. Slightly less than half of the treatment group experienced an improvement of 6 or more in their FMA-UE score.