Northstar’s Renova™ Cortical Stimulation System* is comprised of the following components:

• Implantable pulse generator (IPG) - an electrical stimulator that is implanted in the pectoral (upper chest) area.

• Cortical stimulation lead - an electrode patch connected to the IPG, which is used to deliver stimulation to the cortex. The electrode is placed over the dura, which is the protective membrane that covers the brain's surface.

• Programming system - a handheld computer attached to a programming device, that allows communication with the implanted IPG device. This system allows the clinician to change stimulation parameters and to turn the device on and off.

*Caution: Investigational device. Limited by Federal (or U.S.) law to investigational use.