NeuroPace, Inc. has filed a Premarket Approval Supplement (PMA-S) application with the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication resistant idiopathic generalized epilepsy $(IGE)$ with generalized tonic-clonic seizures. The submission is supported by positive preliminary 18-month data from the NAUTILUS clinical trial. The company aims to provide new treatment options for patients with drug-resistant IGE, who currently lack approved neuromodulation therapies.
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