At the time of the study, some researchers were concerned that stimulation could increase seizures. “There were two patients that seemed to have increased seizures: one in the sham group and one in the treatment group, so it is not felt that stimulation according to these algorithms will cause excessive seizures,” Dr. Sillay noted. Sudden unexpected death in epilepsy was also a concern, but its rate was lower in the treatment group than in the baseline population.
“Altogether, there’s been a very large safety record and almost 1,200 implant years,” Dr. Sillay said. “No real difference in adverse events [was found] between the treatment versus sham groups and adverse events or side effects on the order of those in movement disorder surgery.”
In November 2013, the FDA approved NeuroPace’s RNS System for the treatment of adults with partial-onset seizures that have not been well controlled with two or more antiepileptic drugs.
“In conclusion,” Dr. Sillay said, “the newly approved closed-loop stimulation system by NeuroPace, the RNS system, is a treatment option that has shown improvement.”
—Glenn S. Williams