To use the Vivistim System, an implantable pulse generator (IPG)-which generates a mild electrical pulse-is implanted just under the skin in the chest of the patient. The Vivistim System is intended to be used, along with post-stroke rehabilitation therapy, in patients who have had ischemic stroke, to electrically stimulate the vagus nerve-a nerve that runs from the brain down to the abdomen-to reduce deficiencies in upper limb and extremity motor function and to improve patients’ ability to move their arms and hands. Disabilities resulting from stroke may include, but are not limited to, total or partial paralysis or difficulty with muscle movement. Depending on how long the brain is deprived of blood and where in the brain the stroke occurs, stroke can lead to brain damage, temporary or permanent disabilities, and in some cases, death. There are different types of stroke, but the most common type is ischemic stroke, meaning the blood vessels to the brain become clogged, which blocks blood flow from reaching the brain. Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”Ī 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. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation. Loftus, M.D., acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices. “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” said Christopher M. Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke-a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms-using vagus nerve stimulation (VNS).
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