NeuroPace (Mountain View, CA) will team with the Defense Advanced Research Projects Agency (DARPA) to develop new neurostimulation treatments for epilepsy patients with memory deficits. The project may ultimately benefit patients with other neurological disorders.
NeuroPace's RNS device receiced FDA approval via the PMA pathway.
In November 2013, the FDA approved NeuroPace’s implantable, closed-loop, responsive neurostimulator system (RNS) to treat some adult patients with drug-resistant epilepsy. The agency noted a 38% reduction in total seizure frequency among RNS users in a Feb. 2013 paper presented to its Neurological Devices Advisory Panel.
Patients in the Department of Defense study must have partial-onset seizures with one or two seizure onset zones. The system uses leads containing electrodes placed near those part(s) of the patient’s brain where seizures begin. The device releases small bursts of electrical stimulation to reduce seizure frequency. Physicians can program the RNS to customize individual patients’ treatment.
Patients will receive RNS implants at seven comprehensive epilepsy centers (rated Level 4 by the National Association of Epilepsy Centers)in a portion of the $40 million project led by Barbara Jobst, MD, professor of neurology at Dartmouth College, and NeuroPace’s chief medical officer, Martha Morrell, MD, a clinical professor of neurology at Stanford University. Itzak Fried, MD, PhD, will be principal investigator for the part of the project staged at UCLA.
Implanted medical devices that treat epilepsy are not new. For example, implants are used to treat conditions like dystonia and Parkinson’s disease. Another class of devices utilizes vagal nerve stimulation to treat some types of epilepsy. However, the RNS System is not the same as traditional VNS devices. It continuously monitors the brain’s electrical signals, delivers stimulation when needed and monitors the response, says NeuroPace CEO Frank Fischer.
