The Food and Drug Administration (FDA) announced that they have approved a new rehabilitation technology for patients suffering from ischemic stroke, Friday, August 27. This technology treats stroke patients with moderate to severe motor deficits to help them move.

The MicroTransponder Vivistim Paired VNS System (Vivistim System) is a first-of-its-kind stroke rehabilitation system designed to be used alongside rehabilitation exercises in patients suffering from chronic ischemic stroke.

Food And Drug Administration Headquarters In Maryland
(Photo: Getty Images)
WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)

Ischemic Stroke

According to the Centers for Disease Control & Prevention (CDC), ischemic strokes make up 87% of all types of strokes. Ischemic stroke happens when the blood flowing through the artery, which supplies oxygenated blood to the brain, is blocked by blood clots.

Circulatory conditions are the main risk factors for ischemic stroke because they increase the risk for blood clots. Healthline reported that high blood pressure, atherosclerosis, high cholesterol, atrial fibrillation, prior heart attack, sickle cell anemia, clotting disorders, and congenital heart diseases are some of these conditions that cause ischemic stroke.

Other risk factors also include diabetes, smoking, obesity, excessive alcohol, drug abuse, and people with a family history of stroke. Men are also found to have a higher risk of having an ischemic stroke compared to women.

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How the Vivistim System Works

McKnight's Long-Term Care News reported that the MicroTransponder Vivistim Paired VNS System (Vivistim System) works by electrically stimulating the vagus nerve to help reduce the movement deficits of the patient's arms and hands. The vagus nerve runs from the brain through the face and thorax to the abdomen.

The implantable components of the Vivistim System are accompanied by software that is preloaded onto a laptop and a wireless transmitter that clinicians use to input the appropriate settings. The system includes the patient's healthcare history, amplitude, frequency, pulse width for stimulation, and other data.

During the clinical trial of the Vivistim System, the FDA investigators evaluated the recovery of motor function of patients from the baseline to six weeks of therapy. They found that patients in the treatment group showed significantly higher score increases compared to those in the control group.

Moreover, the FDA reported that 47.2% of those in the treatment group show improvements within 90 days after the therapy compared to only 23.6% in the control group.

"People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function," according to FDA's acting director for the Center for Devices and Radiological Health's Office of Neurological and Physical Medicine Devices, Dr. Christopher M. Loftus in a statement.

He added that the Vivistim System adds another option for stroke patients to remove motor movement deficits using vagus nerve stimulation (VNS). It is a prescription device used in clinical and home settings to provide VNS to stroke patients. Clinicians train their patients on using the Vivistem System at home and its safety features to avoid unwanted electrical stimulation.

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