The Health Canada has granted a medical device license to Medtronic's deep brain stimulation (DBS) therapy for refractory epilepsy patients.
The DBS therapy delivers controlled electrical pulses to a location inside the brain which is involved in seizures to treat refractory epilepsy.
The license was given based on Medtronic’s stimulation of the anterior nucleus of the thalamus in epilepsy (SANTE) clinical trial.
The double-blind, prospective, pivotal and randomized study was designed to assess the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures.
The DBS therapy for refractory epilepsy is also approved in Europe, but is not available for use in the US.
The therapy is licensed in Canada and approved in the European Union (EU) and the US for the treatment of tremor, advanced Parkinson’s disease and dystonia, for which approval in the US is under a humanitarian device exemption (HDE).
The DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the EU and US under an HDE.