MicroTransponder’s Vivistim Paired VNS System Approved for Use in Stroke Rehabilitation Therapy

August 31, 2021—MicroTransponder, Inc. announced FDA premarket approval of the Vivistim paired vagus nerve stimulation (VNS) system, which is intended to be used to stimulate the vagus nerve during rehabilitation therapy to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.

The Vivistim system, which was granted FDA Breakthrough Device designation, will be available in targeted United States markets in late 2021. The device launch will be expanded nationally by the end of 2022. The VNS implantation procedure has been FDA approved as safe and effective for over 20 years in other therapeutic areas, noted MicroTransponder.

According to the company, the device significantly improves the effectiveness of rehabilitation therapy for stroke survivors with moderate to severe upper extremity impairment at 6 months after stroke.

MicroTransponder’s platform pairs VNS with rehabilitation therapy to help improve stroke-related arm and hand deficits. The Vivistim neurostimulation device is placed just under the skin of the chest and neck in a short outpatient procedure. During in-clinic rehabilitation therapy, a therapist pairs gentle pulses of VNS with standard rehabilitation exercises.

The company advised that preclinical data showed that VNS triggers the release of neuromodulators, making rehabilitation therapy more effective by strengthening the neural connections during the rehab exercises. The Vivistim system can also be activated by the user at home during rehabilitation exercises or activities of daily living they wish to improve.

Gerard Francisco, MD, discussed the newly approved Vivistim device in MicroTransponder’s announcement. Dr. Francisco is professor and chair of physical medicine and rehabilitation at McGovern Medical School at The University of Texas Health Science Center and Chief Medical Officer at TIRR Memorial Hermann in Houston, Texas.

“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,” commented Dr. Francisco. “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 company reported that in VNS-REHAB, the 108-patient pivotal study of the device for use during rehabilitation therapy after stroke, patients receiving Vivistim treatment showed statistically significant improvement in upper limb impairment and function compared to patients received intense rehabilitation therapy. The study achieved its FDA-specified primary and secondary endpoints. Quality-of-life data showed that 65% of Vivistim patients reported clinically significant improvement in their ability to perform activities of daily living.

In April, the VNS-REBAB results were published by Jesse Dawson, MD, et al in The Lancet (2021;397:1545-1553).