I was excited to find that The MicroTransponder Vivistim Paired VNS System was approved on August 27, 2021, by the U.S. Food and Drug Administration. I am grateful to the two articles which I used as sources to write this post. You can read them at:
The Vivistim System is a unique, drug-free rehabilitation system intended for chronic ischemic stroke thivors. This saying that the patient had long-term effects. The system is designed to treat moderate to severe upper extremity motor deficits (you cannot move your shoulder, arm, and hand) from a stroke. The system is using the vagus nerve stimulation (VNS). For the 7 million Americans that live with a stroke, ischemic (blockage) strokes are the most common, accounting for approximately 70% of all cases (Baird, 2013). The System increasing the effectiveness of physical rehabilitation for mobility and motor skills and could provide a transformative boost in quality of life.
The vagus nerve establishes one of the connections between the brain and the gastrointestinal tract and sends information about the state of the inner organs to the brain. The vagus nerve has a long path through the human body. It starts in the brainstem, then it goes through the neck and the chest down to the belly. It oversees a vast array of crucial bodily functions, including control of mood, immune response, digestion, and heart rate.
A stroke occurs when blood flow to part of the brain is interrupted, causing brain cells to die from a lack of oxygen and nutrients contained in the blood. In this stroke, the blood vessels to the brain become clogged. This blocks blood flow from reaching the part of the brain. The loss of blood, oxygen, and nutrients leads to temporary or permanent brain damage, altered function of the body, and in some cases, death. The altered function can cause total or partial paralysis or difficulty with muscle movement.
The Vivistim System is electrically stimulating the vagus nerve to improve patients’ ability to move their arms and hands. The System uses a device that generates a mild electrical pulse to the nerve. The device is implanted just under the skin in the chest of the patient. There is a wireless computer that adjusts the device. Way cool!
The stroke warrior must get a prescription to have the Vivistim System implanted. The patients are trained on how to use the Vivistim System at home, as well as its safety features, to avoid any unwanted electrical stimulation. The FDA evaluated the safety and effectiveness of the Vivistim System in a clinical study of 108 patients at 19 clinical sites in the U.S. and the U.K. This study showed that in patients with arm and hand weakness after a stroke, pairing VNS with rehabilitation exercises led to improvements that were two to three times greater than the control group receiving rehabilitation alone.
I had two ischemic strokes in 2010 and I still have long-term impairment of the muscles of the right side of my body. I would be eligible and I am considering it. We will keep you of any changes in this exciting therapy that could be a breakthrough to numerous stroke patients.
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