Non-Invasive Neurostimulation System, Well-Received in Europe , Now Available in Canada for Adults and Children 9 years and older LOS ANGELES , May 2, 2013 /CNW/ - NeuroSigma, Inc., a California-based medical device company, today announced that it has received a Class 2 medical device license for its Monarch eTNS (external trigeminal nerve stimulation) System from Health Canada . The license covers the use of the Monarch eTNS System for treatment of drug-resistant epilepsy (DRE), major depressive disorder (MDD), and treatment-resistant depression. (Photo: http://photos.prnewswire.com/prnh/20130502/LA06314) The Monarch, CE Mark approved in the European Union in 2012, but not yet approved in the United States (US), is now available to patients in Canada . Drug resistant epilepsy (DRE) is a serious medical disorder, and affects approximately 30% of all patients with epilepsy. Major depressive disorder is a prevalent condition, affecting up to 16% of the population at some point during their lives. The Health Canada approval was supported by years of safety and efficacy data generated in Phase I and Phase II clinical trials in the US, in which the therapy was shown to substantially reduce seizure frequency and significantly improve mood. Results from a Phase II Randomized Controlled Trial of eTNS … Continue reading
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