NeuroSigma’s Monarch System for Epilepsy Designated an FDA Breakthrough Device

February 28, 2022

Los Angeles-based NeuroSigma has received a Breakthrough Device designation from the FDA for its Monarch eTNS (external trigeminal nerve stimulation) system for the treatment of epilepsy.

An adjunctive treatment for patients with drug-resistant epilepsy, the investigational device is designed to reduce the frequency of seizures in individuals with epilepsy “characterized by partial-onset seizures, with or without secondary generalization, that are refractory to two or more antiepileptic medications,” the company said.

Drug-resistant epilepsy occurs in approximately 30 percent of epilepsy patients, resulting in increased risk of death, psychological disorders and other severely debilitating conditions.

The Monarch eTNS system is currently being evaluated in a late-stage trial.

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