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August 30, 2021

FDA grants approval to MicroTransponder rehabilitation system for stroke

The stroke rehabilitation system is designed to treat moderate to severe upper extremity motor deficits with chronic ischemic stroke.

The US Food and Drug Administration (FDA) has approved the MicroTransponder Vivistim paired VNS system (Vivistim System), a first-of-its-kind, stroke rehabilitation system.

Manufactured by MicroTransponder, the drug-free rehabilitation system uses vagus nerve stimulation (VNS) and is designed to treat moderate to severe upper extremity motor deficits that are associated with chronic ischemic stroke.

Together with post-stroke rehabilitation therapy, the device electrically stimulates the vagus nerve in patients who have had ischemic stroke to reduce shortages in upper limb and extremity motor functioning.

It also helps to improve ability of the patient to move their arms and hands.

An implantable pulse generator, which generates a mild electrical pulse, 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.

FDA Center for Devices and Radiological Health Neurological and Physical Medicine Devices Office acting director 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.

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“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.”

Health care providers can use the system’s software and a wireless transmitter to input appropriate settings on the IPG such as frequency, amplitude, and pulse width for the stimulation and to access stimulation history and other data about the IPG.

The safety and effectiveness of the Vivistim System has been evaluated by the FDA in a clinical study conducted on 108 patients at 19 clinical sites in the US and the UK who received the Vivistim System.

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