Medtronic Receives Health Canada License for Deep Brain Stimulation Therapy in Refractory Epilepsy Patients
March 15 2012 - 10:05AM
Business Wire
Medtronic, Inc. (NYSE: MDT) today announced that it has received
from Health Canada a license 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 license 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
centers 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 HDE2.
“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™
neurostimulator for chronic pain, another Medtronic first. ”
Medtronic’s Leadership in NeuromodulationMedtronic
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™ neurostimulator with
AdaptiveStim™ 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 MedtronicMedtronic, 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.
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