Vivistim is claimed to be the first-of-its-kind system to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation
The FDA has approved Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
MicroTransponder has secured approval from the US Food and Drug Administration (FDA) for its Vivistim Paired VNS System, a drug-free stroke rehabilitation system.
Vivistim System is claimed to be the first-of-its-kind system to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS).
The system is a prescription device, which can be used in both clinical and at-home settings to deliver VNS.
It is developed to be used along with post-stroke rehabilitation therapy to treat patients who have had an ischemic stroke.
The FDA’s Center for Devices and Radiological Health’s office neurological and Physical Medicine Devices acting director Dr Christopher Loftus said: “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.
“Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation. Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”
The Vivistim system will help electrically stimulate the vagus nerve, which runs from the brain down to the abdomen, to minimise deficiencies in upper limb and extremity motor function and enhance patients’ ability to move their arms and hands.
An implantable pulse generator (IPG), which generates a mild electrical pulse, is placed just under the skin in the chest of the patient to use the Vivistim System.
The clinician software preloaded onto a laptop and wireless transmitter will be used along with implantable components.
The software enables the health care providers to manage a patient’s rehabilitation to input the appropriate settings on the IPG, including amplitude, frequency, and pulse width for the stimulation.
In addition, the software also helps to record stimulation history, movements performed, and information about the IPG. The wireless transmitter facilitates adjustments to the IPG settings with the support of the software.
MicroTransponder’s system is assessed by the FDA in a clinical trial of 108 patients at 19 clinical sites in the US and the UK.