Medtronic Receives Health Canada License for Deep Brain Stimulation Therapy in Refractory Epilepsy Patients
March 15 2012 - 10:00AM
Marketwired
Medtronic, Inc. (NYSE:MDT) today announced that it has received
from Health Canada a licence for Medtronic Deep Brain Stimulation
(DBS) Therapy for refractory epilepsy patients. Medtronic DBS
therapy for refractory epilepsy delivers controlled electrical
pulses to a location inside the brain which is involved in
seizures.
The Health Canada licence was based on data collected in
Medtronic's clinical trial called SANTE® (Stimulation of the
Anterior Nucleus of the Thalamus in Epilepsy). The SANTE trial was
a prospective, randomized, double-blind pivotal study to evaluate
the use of DBS therapy for patients with medically refractory
epilepsy with partial-onset seizures. The trial collected data from
110 patients who were implanted with a Medtronic DBS system at 17
centres in the United States.
Medtronic DBS Therapy for refractory epilepsy is also approved
in Europe. The therapy is not currently approved by the U.S. Food
and Drug Administration for use in the United States for the
treatment of refractory epilepsy.
To date, more than 85,000 patients worldwide have received
Medtronic DBS therapy. The therapy is currently licensed in Canada
and approved in other regions including the European Union and the
United States, for the treatment of the disabling symptoms of
essential tremor, advanced Parkinson's disease and dystonia, for
which approval in the United States is under a Humanitarian Device
Exemption (HDE)(1). The therapy is also approved for the treatment
of severe, treatment-resistant obsessive-compulsive disorder not
adequately controlled by medications in the European Union and in
the United States under an HDE(2).
"Medtronic is a pioneer in the field of neuromodulation," said
Lothar Krinke, Ph.D., vice president and general manager for the
Deep Brain Stimulation business in Medtronic's Neuromodulation
division. "We are proud of the expansion of indications to include
epilepsy, which will allow more patients to benefit from our DBS
therapy. This Medtronic First innovation provides a viable option
for patients who are not responsive to other therapies. This
follows closely the Canadian launch of the RestoreSensor(TM)
neurostimulator for chronic pain, another Medtronic first."
Medtronic's Leadership in Neuromodulation
Medtronic developed and leads the field of neuromodulation, the
targeted and regulated delivery of electrical pulses and
pharmaceuticals to specific sites in the nervous system. 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.
Medtronic of Canada's innovative neuromodulation portfolio
includes the following technologies:
-- RestoreSensor(TM)neurostimulator with AdaptiveStim(TM) technology: the
world's first and only pain-management device 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.
-- Activa® PC (Primary Cell), Activa® SC (Single Channel), and
Activa® RC (Rechargeable Cell): The Activa line of neurostimulators
includes the first rechargeable neurostimulator in Canada, with all
three products featuring the most advanced multi-programming
capabilities in Canada. Activa® PC is the neurostimulator licensed for
use in refractory epilepsy. Only the ACTIVA family of neurostimulators
provides clinicians with the ability to deliver stimulation in constant
voltage or constant current mode, providing physicians with a choice
based on their preference and clinical needs.
About Medtronic of Canada Ltd.
Medtronic of Canada (www.medtronic.ca) sells, services and
distributes Medtronic products in Canada: medical devices used in
cardiovascular medicine, diabetes, spinal and neurosurgery, and
ear, nose and throat surgery. Medtronic of Canada employs over 745
Canadians, it is headquartered in Brampton, Ontario, has regional
offices in Vancouver and Montreal and an atrial fibrillation (AF)
ablation catheter manufacturing facility - Medtronic CryoCath - in
the Montreal metropolitan area.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in
Minneapolis, is the global leader in medical technology -
alleviating pain, restoring health, and extending life for millions
of people around the world.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission.
(1) Humanitarian Device in the U.S.: The effectiveness of this device for
the treatment of dystonia has not been demonstrated.
(2) Humanitarian Device in the U.S.: The effectiveness of this device for
the treatment of obsessive-compulsive disorder has not been demonstrated.
Contacts: Medtronic of Canada, Ltd. Melicent Lavers-Sailly
Public Relations 905-460-3681 Medtronic of Canada, Ltd. Donna
Marquard Public Relations 763-526-6248 Medtronic of Canada, Ltd.
Jeff Warren Investor Relations 763-505-2696