FDA Grants Premarket Approval to Neurostimulation Device for Assistive Rehabilitation After Stroke

The Food and Drug Administration (FDA) granted premarket approval to a neurostimulation device (Vivistim Paired VNS System; Microsponder, Dallas, TX) that assists poststroke upper extremity rehabilitation. With the subcutaneously implanted device, pulsed neurostimulation of the vagus nerve is paired with standard rehabilitation exercises.

In the VNS-REHAB study (NCT03131960) of 108 participants with moderate-to-severe upper extremity impairment, neurostimulation resulted in superior functional improvement compared with intense rehabilitation therapy (P<0.01). Quality of life data showed 65% of those who used the neurostimulation device had clinically significant improvement in their ability to perform activities of daily living. 

“One of the most frustrating things for our patients who had a stroke is the inability to perform activities of daily living because of the weakness of the upper limb,” said Gerard Francisco, MD, professor and chair of physical medicine and rehabilitation, McGovern Medical School, The University of Texas Health Science Center; and chief medical officer, TIRR Memorial Hermann. “The current therapies we prescribe are quite limited. Many of these therapies have not been shown to induce the neuroplastic changes important for long-lasting recovery. We are excited to offer our patients the Vivistim System to magnify their potential to recover further.” 

The device is placed under the skin of the chest and neck in a short outpatient procedure. Adverse events in the VNS-REHAB study included but were not limited to dysphonia, bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection, and fatigue.