NeuroPace Receives IDE Approval to Initiate NAUTILUS Pivotal Study of its RNS System for Idiopathic Generalized Epilepsy

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[{"type":"text","content":"IDE study will be first to evaluate the effectiveness of brain-responsive neuromodulation to treat primary generalized epilepsy in patients aged 12 and older MOUNTAIN VIEW, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc., a medical technology company dedicated to transforming the lives of people suffering from epilepsy, today announced that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to study the company’s RNS® System in patients with drug-resistant idiopathic generalized epilepsy. Idiopathic generalized epilepsy (IGE) is the second most common type of epilepsy, after focal epilepsy.1 In the approximately one-third of IGE patients who are not effectively treated with medications, this disorder is debilitating, has substantial impact on day-to-day life, and carries risk for social and psychiatric disability, injury and premature death. The NAUTILUS pivotal study will be the first in the United States to evaluate use of brain-responsive neuromodulation for the treatment of IGE. It is a prospective single blind, multi-center, randomized study that is projected to start enrolling patients in 2022. “We are pleased with FDA’s decision to grant IDE approval for the pivotal study, allowing us to evaluate the safety and effectiveness of the RNS System in patients who are living with drug-resistant, idiopathic generalized epilepsy,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “We look forward to working closely with the study investigators to evaluate a new treatment option that could potentially improve quality of life for these individuals in a meaningful way.” The RNS System is the only FDA-approved brain-responsive neuromodulation system that delivers personalized, targeted treatment at the seizure source in patients with drug-resistant focal epilepsy. Unlike other neuromodulation devices, the RNS System is a closed-loop technology that monitors and responds to a patient's unique brain patterns to deliver therapy in real time – when and where it is needed – typically before clinical symptoms occur. In March 2021, the company received Breakthrough Device Designation status from the FDA for the potential use of its RNS System to treat idiopathic generalized epilepsy. The Breakthrough Devices Program aims to speed development and assessment of devic...

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