US-based NeuroPace has received the US Food and Drug Administration (FDA) premarket approval for its NeuroPace RNS system, designed to treat partial onset seizures that have not been controlled with two or more antiepileptic medications in individuals 18 years of age or older.
The RNS system consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.
The device delivers small amount of electrical energy to disrupt abnormal brain activity before it gets out of control.
Physicians can program the detection and stimulation parameters of the implanted RNS neurostimulator non-invasively to customize therapy for each individual.
NeuroPace CEO Frank Fischer said the company believes the RNS system has the potential to provide substantial improvement in quality of life to hundreds of thousands of people diagnosed with epilepsy in the US who are unable to achieve seizure control with medications.
"We anticipate that physicians will be able to make this breakthrough therapy available to eligible patients in the very near future," Fischer added.
The FDA's clearance is supported by a three-month randomized control trial of 191 patients with drug-resistant epilepsy.
A total of 256 patients have been implanted with the RNS system, and more than 1,200 patient years of experience with responsive stimulation have been accumulated to date.
Image: RNS System Photo:courtesy of Business Wire/NeuroPace, Inc.