The findings suggest that responsive neurostimulation might be a promising treatment option for patients with seizures that are resistant to conventional antiepileptic therapy. The apparent increase in the number of patients experiencing at least a 50% reduction in seizure frequency relative to baseline during the open-label phase of the study suggests the system might become more effective over time, she noted.
The system has not yet received Food and Drug Administration approval, but NeuroPace plans to submit a premarket approval application to the FDA in early 2010, Dr. Morrell said.