ABSTRACT

The NeuroCybemetic Prosthesis (NCP), is an implantable, multiprogrammable pulse generator that delivers biphasic, constant current electrical signals to the vagus nerve for the purpose of reducing the frequency or severity of epileptic seizures. The Food and Drug Administration approved an investigational device exemption based on animal efficacy and safety studies (primarily in the primate) for evaluation in humans using the vagal nerve stimulator technique evolved from cardiac pacemakers. The vagal stimulation bipolar lead conveys the electrical signals from the NCP to the vagus nerve. The electrodes are wrapped around the vagus nerve, and the connector end is tunneled subcutaneously to the NCP pulse generator in the chest. The left vagus nerve is then easily isolated from the carotid artery and jugular vein. The stimulation electrodes are placed around the vagus nerve at or above the omohyoid muscle. An x-ray of the electrode location is taken to document the location of the electrode around the vagus nerve.