MicroTransponder Vivistim Paired VNS System; Image credit: MicroTransponder
The Food and Drug Administration has approved drug-free rehabilitation technology that treats moderate to severe upper extremity motor deficits in certain stroke patients.
The MicroTransponder Vivistim Paired VNS System (Vivistim System), is a prescription system that is designed to be used along with rehabilitation exercises in patients recovering from long-lasting symptoms of chronic ischemic stroke, the agency announced Friday.
The Vivistim System electrically stimulates the vagus nerve, which runs from the brain down to the abdomen, to help improve patients’ ability to move their arms and hands. An implantable pulse generator is placed just under the skin in the patient’s chest, and connected to electrodes at the vagus nerve on the left side of the neck.
Clinicians can use the system’s software and a wireless transmitter to input the appropriate settings, including amplitude, frequency, and pulse width for the stimulation and to access history and other data.
FDA investigators have evaluated the Vivistim System in a clinical trial. Recovery of motor function was examined from baseline to six weeks of therapy. Patients in the treatment group had significantly higher score increases in a standardized measurement when compared with their peers in a control group. In addition, 47% of treatment group participants saw a set improvement in their scores 90 days post-therapy as compared with 24% in the control group, the agency reported.
“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. Loftus, M.D., acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices.
The Vivistem System for the first time gives patients the option to use vagus nerve stimulation, he said.
Electrical Nerve Stimulator
Food and Drug Administration