Medtronic (NYSE:MDT) announced Thursday that the company’s Deep Brain Stimulation therapy has been approved to treat refractory epilepsy patients in Canada.
Refractory epilepsy patients suffer from recurring seizures that cannot be controlled by medication.
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The Canadian approval was based on the results of a randomized, controlled, double-blind study that observed 110 patients who were implanted with the Medtronic DBS system in 17 medical centers in the U.S.
The Activa PC is the neurostimulator that has been approved for providing the therapy to refractory epilepsy patients and it functions by delivering electrical pulses to a region in the brain that is involved in seizures.
Aside from Canada, the DBS system for refractory epilepsy is approved in Europe. However, the system is not approved for refractory epilepsy patients in the U.S., despite an advisory panel’s positive recommendation to the U.S. Food and Drug Administration in 2010.
A Medtronic spokeswoman would not say why the agency has not approved it. Usually, the FDA approves products that an advisory panel clears.
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“It’s premature to discuss details,” said Donna Marquard. “We are continuing to work with the FDA.”
An FDA spokeswoman was not immediately available.
In the U.S., the Activa line of products is approved to treat advanced Parkinson’s disease and dystonia, among other conditions.
The Activa line of products are part of the Neuromodulation Division. In the third fiscal quarter ended Jan. 27, the division saw revenue increase 4 percent to $419 million in the company.
