EU approve Monarch eTNS system (NeuroSigma) for treatment of Epilepsy

The EU have given CE Certification to the Monarch external Trigeminal Nerve Stimulation (eTNS) system, from NeuroSigma, for the adjunctive treatment of Epilepsy and major depressive disorder, for adults and children 9 years and older. Monarch is composed of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily. The patches can be worn primarily in the evening while asleep. The application was supported by clinical studies conducted at the University of California, Los Angeles and the University of Southern California which show that the Monarch eTNS was well tolerated and has been shown to substantially reduce seizures in patients with Epilepsy and improve mood in patients with depression. The company will be submitting a request to the FDA for an Investigational Device Exemption to commence a multi-center eTNS pivotal trial in Epilepsy.