Updated: Apr 8
The Vivistim® Paired VNS™ System, manufactured by MicroTransponder® Inc., is a first-of-its-kind, drug-free rehabilitation system, approved by the U.S. Food and Drug Administration in 2021 to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS). The Vivistim System, a prescription device, may be used in both clinical and at-home settings to enhance the relevance of physical and occupational therapy and help generate two to three times more hand and arm function for stroke survivors than rehabilitation therapy alone.
“Ischemic stroke survivors often have limited mobility and motor function in their hands and arms due to their stroke. Paired VNS™ Therapy is the first stroke rehabilitation intervention that uses vagus nerve stimulation, an extensively researched treatment option for several neurological conditions.” says Ravi H. Gandhi, MD – Neurosurgeon and Partner at Orlando Neurosurgery (shown here performing the procedure)
Dr. Gandhi continues, “When used in conjunction with rehabilitative exercise, this Paired VNS Therapy may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”
The Vivistim System is ideal for chronic ischemic stroke survivors who have not regained arm and hand function six months after their stroke and are considered by their physician to have moderate to severe impairment.
The Vivistim System is intended to be used by ischemic stroke survivors during post-stroke physical or occupational therapy to electrically stimulate the vagus nerve—a nerve that runs from the brain down to the abdomen—a part of the autonomic nervous system that controls involuntary body functions.
Once cleared to begin Paired VNS Therapy after the screening process, ischemic stroke survivors will have an outpatient procedure where a neurosurgeon will place Vivistim under the skin in the upper left chest area. The medical device is small enough to fit in the palm of your hand.
One-to-two weeks after the Vivistim device is placed, the stroke survivor begins in-clinic physical therapy or occupational therapy. During rehabilitation therapy, a therapist will use a wireless transmitter that communicates with proprietary software to signal the Vivistim device to deliver a gentle pulse to the vagus nerve while the stroke survivor performs a specific task, such as putting on a hat, brushing hair or cutting food, etc. This simultaneous pairing of the rehabilitation exercise with vagus nerve stimulation releases neuromodulators that help create or strengthen neural connections to improve upper limb function and increase the relevance of physical therapy.
“We are enthusiastic about our patients’ progress with the Vivistim System,” said Amanda Saylor, OTR/L, CNS, CBIS, divisional occupational therapy lead for AdventHealth Sports Med and Rehab. “Our goal for every stroke survivor is to strengthen their affected side so they can get back to the activities they love most. With this innovation, we are giving people back some hope.”
Ischemic stroke survivors across the country are using the Vivistim System and say that the Paired VNS Therapy has helped them enhance their quality of life by improving their hand and arm function. To learn more about their Vivistim Victories, read clinical perspectives or review safety information, visit Vivistim.com.
Shown here: Orlando Neurosurgery - Dr. Ravi H. Gandhi, MD, Sara Fisher, Melissa Torres
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