NeuroPace publishes 82% seizure reduction at 3 years in Neurology — largest FDA-reviewed prospective DRE neuromodulation study ever
Summary
NeuroPace announced publication of 3-year results from the RNS System Post-Approval Study (PAS) in Neurology — the most respected neurology journal — showing 82% median seizure reduction in drug-resistant focal epilepsy patients at 3 years of RNS therapy. The PAS is the largest FDA-reviewed prospective neuromodulation study for focal drug-resistant epilepsy ever conducted, enrolling 324 implanted patients across 32 US centers. The 82% median seizure reduction at 3 years represents progressive improvement over time — early RNS data typically showed 50-60% reduction, reflecting the device's machine learning capability to improve seizure detection and response accuracy the longer it is implanted. NeuroPace Chief Medical Officer Martha Morrell: "The publication of the 3-year PAS results in Neurology represents an important milestone for the epilepsy community and adds to the robust body of evidence supporting the RNS System."
Why it matters
Publication of 82% median seizure reduction at 3 years in Neurology is the most definitive long-term evidence ever published for closed-loop responsive neurostimulation for epilepsy. The progressive improvement over time — the RNS System's machine learning getting better at detecting each patient's seizure pattern — is the closed-loop BCI principle validated at 3-year clinical scale. This data will transform the evidence landscape for the FDA PMA Supplement application for IGE indication expansion currently under review.
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