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NeuroPace Files PMA Supplement to FDA Seeking Expanded RNS® System Indication for Idiopathic Generalized Epilepsy

Neuropace, Inc. (NPCE) 
Company Research Source: Business Wire
-- Submission supported by positive preliminary 18-month NAUTILUS data in patients with drug-resistant idiopathic generalized epilepsy (IGE) and generalized tonic-clonic (GTC) seizures -- MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that it has filed a Premarket Approval Supplement (PMA-S) application to the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS® System to include patients with antiseizure-medication (ASM) resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures.The PMA-S is supported by positive preliminary results from the NAUTILUS trial, which demonstrated robust 77% median GTC seizure reduction and a favorable safety profile in this highly refractory patient population at 18 months of therapy. The RNS System has been granted Breakthrough Device Designation for th Show less Read more
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