FDA Approves Stroke Rehabilitation System
The U.S. Food and Drug Administration (FDA) on Aug. 27 approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a drug-free rehabilitation system that uses vagus nerve stimulation to treat moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke.
The Vivistim System is used by implanting a lead wire under the skin of a patient’s chest that leads to electrodes that are placed on the left side of the neck near the vagus nerve. The system is intended to be used along with post-stroke rehabilitation therapy.
The system was granted Breakthrough Device designation, which is used for devices that treat or diagnose a life-threatening or irreversibly debilitating disease or condition. The FDA reviewed the system under the agency’s Premarket Approval pathway, which is FDA’s most stringent device marketing application and is based on a determination by FDA that the application contains sufficient valid scientific evidence to ensure the device is safe and effective for its intended use. For additional information, read the full FDA press release.
Clinical Topics: Vascular Medicine
Keywords: Stroke Rehabilitation, Vagus Nerve Stimulation, Brain Ischemia, United States Food and Drug Administration, Stroke, Upper Extremity, Vagus Nerve, Brain Damage, Chronic, Ischemia, Electrodes, Ischemic Stroke, ACC Advocacy
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