RNS System is the commercially available implantable closed-loop responsive neurostimulator system.
In November 2013, the US Food and Drug Administration (FDA) had given premarket approval (PMA) for the RNS System.
The system has been approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.
RNS System is said to monitor the brain’s own signals. It interprets these signals and provides stimulation when needed and then assesses the brain’s response.
According to the company, RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study.
NeuroPace CEO Frank Fischer said the epilepsy centers have moved quickly since PMA approval to make the RNS System available.
"To date, 35 Comprehensive Epilepsy Centers that meet all the qualifications for the highest level of epilepsy care have completed required training and are able to implant the RNS System," Fischer added.
