NeuroSigma, discovered breakthrough Monarch eTNS System® Drug-Resistant Epilepsy (DRE).
Monarch eTNS System® is designed for individuals with 18 years of age or older to lower the frequency of seizures diagnosed with epilepsy specified by partial-onset seizures, with or without secondary generalization, that are refractory to two or more antiepileptic medications.
Monarch eTNS System helps in providing more effective treatments for life-threatening or irreversibly debilitating human diseases and conditions.
It is observed that 30 per cent of epilepsy patients consists of Drug-resistant epilepsy (DRE). Some of the serious complications observed in DRE are psychological disorders, rising death rates and other severely debilitating conditions.
Alternatives to antiepileptic drugs (AEDs) and surgery are a significant unmeed medical need for patients with incomplete seizure control.
Compared with adjunctive pharmaceutical and implantable device therapies, the results achieved with clinical trials of Monarch eTNS System® has shown positive results. Moreover, for various number of serious diseases, Monarch eTNS System is demonstrated to be the safe and effective alternative to drug-based or surgical treatments.
US Food and Drug Administration (FDA) grants Breakthrough Device Designation for Monarch eTNS System®.