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Medtronic CE marks DBS therapy for epilepsy

This article was originally published in Clinica

Executive Summary

Medtronic has CE marked its deep brain stimulation (DBS) therapy for sale in Europe as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy. The device delivers electrical pulses to the anterior nucleus of the thalamus, which is part of a neurological circuit involved in seizures, and will be released to "expert epilepsy centres across Europe" by the end of the year, Medtronic said. Use of the product for epilepsy is under review by the US FDA, which recently requested additional clinical data to support Medtronic’s premarket approval (PMA) application. Medtronic DBS therapy is currently approved in Europe and the US for the treatment of the disabling symptoms of essential tremor and advanced Parkinson's disease. It is approved in Europe for dystonia and obsessive-compulsive disorder (OCD), and in the US the use of DBS for dystonia and treatment-resistant OCD is approved under a Humanitarian Device Exemption (HDE).

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