Medgadget

NeuroPace Gets FDA Pre-Market Approval for RNS Stimulator

NeuroPace has received FDA pre-market approval for the NeuroPace RNS System, used to treat medically refractory partial epilepsy. The battery powered device is implanted in the cranium and monitors electrical activity in the brain. If abnormal activity is detected, electrical impulses are sent to the seizure focus in the brain via leads, helping to prevent the onset of a seizure. The RNS System also comes with a programmer for physicians to non-invasively set the detection and stimulation parameters for the implanted device, and has the ability to view the patients electrocorticogram (ECoG) in real time and upload previously recorded ECoGs stored on the RNS implant.

Results from clinical studies show significant benefits for patients, with a 37.9% reduction in seizure frequency for subjects with active implants. Follow up with patients two years post-implant showed that over half experienced a reduction in seizures of 50% or more. The device also met the FDA safety criteria by demonstrating equivalency to current devices and procedures From the announcement, the FDA approved indication:

“The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).”

Flashbacks: NeuroPace: Maybe First Since Jesus to Prevent and Treat Epilepsy…; Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study…; NeuroPace Seeks FDA Approval for Its RNS System…

Product page: NeuroPace RNS System…

Press release: FDA Grants Premarket Approval (PMA) for the NeuroPace® RNS® System to treat Medically Refractory Epilepsy…