NeuroPace files PMA Supplement for IGE indication — first closed-loop neuromodulation for generalized epilepsy under FDA review
Summary
NeuroPace filed a Premarket Approval Supplement (PMA-S) to the FDA in December 2025 seeking to expand the labeled RNS System indication to include patients with antiseizure-medication resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures. The application is currently under FDA review. If approved, RNS would become the first and only neuromodulation therapy cleared for IGE — a condition affecting millions of epilepsy patients with a 30% non-response rate to medications and no surgical options. The NAUTILUS trial generated the pivotal evidence supporting the PMA Supplement.
Why it matters
The IGE PMA Supplement represents the single most commercially important regulatory submission in NeuroPace's history — potentially doubling or tripling their addressable epilepsy patient population beyond current focal DRE. IGE patients include juvenile myoclonic epilepsy, juvenile absence epilepsy, and childhood absence epilepsy with GTC seizures — large patient populations who have been historically excluded from all device therapy options due to the absence of a defined focal seizure onset zone.
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