NeuroPace has submitted its premarket approval (PMA) application to the FDA for its RNS System, an investigational device that utilises responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur.
The PMA application is for an indication to treat people with medically refractory partial onset epilepsy originating from one or two locations in the brain. Partial onset epilepsy is a common form of the disorder that is difficult to treat with medication. The results from the company’s pivotal trial were included in the PMA application.
NeuroPace said that the RNS System continuously monitors brain electrical activity and, after identifying a preprogrammed abnormal pattern, delivers brief and mild electrical stimulation with the intention of suppressing the seizure before symptoms occur.
The pivotal trial is a randomized, double-blind, sham stimulation controlled investigation of patients with partial onset epilepsy that previously had failed to achieve seizure control with two or more antiepileptic drugs.
The primary effectiveness endpoint was to demonstrate a significantly greater reduction in seizure frequency in the treatment group (responsive stimulation on) compared to the sham stimulation group (responsive stimulation off) during the three month blinded evaluation period.
The trial also demonstrated a serious adverse event rate less than comparative surgical procedures. There were no serious unanticipated device related adverse events reported in the trial, and there was no difference between the treatment and sham stimulation groups when comparing the rate of adverse events, including depression, memory impairment and anxiety.
David Roberts, chief of neurosurgery at Dartmouth-Hitchcock Medical Center, said: “The clinical data support that this unique technology can provide an effective method to significantly reduce seizure frequency with a positive safety profile for people with partial onset epilepsy.
“The RNS System has the potential to meaningfully improve quality of life for many people who are currently living with uncontrollable seizures.”
Frank Fischer, CEO of NeuroPace, said: “We look forward to working with the FDA during the review process, and firmly believe the RNS System has the potential to provide an invaluable additional treatment option for people living with epilepsy.”