Northstar’s Renova™ Cortical Stimulation System* is designed to deliver targeted stimulation to the cerebral cortex. The cerebral cortex is the outer layer of the brain and plays a central role in many complex brain functions including movement, behavior, perceptual awareness, language, vision and hearing. Evidence suggests that targeted stimulation of certain areas of the left dorsolateral prefrontal cortex—an area involved with reasoning and emotion—may help treat major depressive disorder.

Cortical stimulation involves a neurosurgical procedure to place an electrode over the brain’s cortex. The electrode is then connected via a lead wire to a neurostimulator implanted in the patient's chest. The pacemaker-sized neurostimulator and lead wire are implanted under the skin. The device is permanently implanted and can deliver continuousstimulation to the brain which is not felt by the patient. Theraputic stimulation is controlled by a clinician using Northstar’s programming system.

The Renova™ System consists of a neurostimulator, cortical stimulation lead and a programming system.

• Neurostimulator - an electrical stimulator that is implanted in the upper chest area.
• Cortical stimulation lead - an electrode connected to the neurostimulator, which is used to deliver stimulation to the cortex. The electrode is placed over the cortex.
• Programming system - a handheld computer, which allows communication with the implanted neurostimulator. This system allows the clinician to change stimulation parameters.
  

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