A CE certification, or the clearing of European health officials, has been given to NeuroSigma to use its Trigeminal Nerve Stimulation (eTNS) system as a treatment for epilepsy. The new eTNS system is called the Monarch.
The Monarch is going to be used as both an epilepsy treatment and a depression treatment. The only requirement on who will receive the treatment is that they be nine years of age or older. NeuroSigma has said that the eTNS system will be prescribed by a physician in the European Union. The system is made up of an external pulse generator and various disposable electric patches that will be placed on the patient’s forehead on a daily basis. This treatment will be used while the patient sleeps so that it doesn’t disrupt them in going about their daily lives. The goal is to have the system available for use in epilepsy and depression centers across the continent. If it works, it may replace antidepressants and epilepsy drugs like Topamax.
“We are proud to successfully complete the CE marking process. It is a major milestone for NeuroSigma and will enhance our efforts to transform the way epilepsy and depression are managed,” said Lodwrick Cook, chairman of NeuroSigma.
The CEO of NeuroSigma, Leon Ekchian, said that the company is most interested in making sure that the eTNS system is affordable widely available as soon as possible. He plans to start commercializing the system right away. The vice president of neurology at NeuroSigma (who is also a professor of Neurology at the University of California, Los Angeles School of Medicine), Dr. Christopher DeGiorgio, has expressed that getting the CE certification was the best day of his life.
“I am especially grateful to NeuroSigma’s management team for their faith in this technology and for their vision and commitment to patients suffering epilepsy and depression,” DeGiorgio says.
It may also wind up being the best moment in the lives of thousands of epileptics all over the world as well. Right now, most epileptics take prescription drugs like Topamax to treat their conditions, but those drugs are causing them to suffer from serious adverse side effects. Topamax has been linked to birth defects in babies born to mothers that use the drug while pregnant. Some of those birth defects include PPHN, oral clefts, neural tube defects and spina bifida.
If your baby was born with birth defects after in-utero exposure to Topamax, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your child’s injuries.
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