US-based medical technology provider Medtronic has received a Health Canada licence for its deep brain stimulation (DBS) therapy for treating patients with refractory epilepsy.
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain.
The Health Canada licence was based on data from the Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (SANTE) clinical trial.
In the prospective randomised double-blind pivotal SANTE trial, 110 patients were implanted with Medtronic's DBS system at 17 centres in the US, to assess the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures.
Medtronic's RestoreSensor neurostimulator with AdaptiveStim technology is designed to sense a change in the patient's body position or activity and automatically adjust stimulation to deliver the right amount of pain relief.
The Activa line of neurostimulators, such as the Activa Primary Cell, Activa Single Channel and Activa Rechargeable Cell provides clinicians with the ability to deliver stimulation in constant voltage or constant current mode, enabling physicians with a choice based on their preference and clinical needs.
DBS therapy is currently licensed in Canada and the European Union for the treatment of the disabling symptoms of essential tremors, advanced Parkinson's disease and dystonia, for which it is under a humanitarian device exemption (HDE) in the US.
The company's Neuromodulation business includes neurostimulation and implantable, targeted drug delivery systems for the management of chronic pain, common movement disorders, spasticity and urologic and gastrointestinal disorders.
Image: Medtronic World Headquarters, Fridley, Minnesota, US. Photo: Bobak Ha'Eri.