BRAMPTON, Ontario & MINNEAPOLIS, Mar 15, 2012 (BUSINESS WIRE) --
Medtronic, Inc.
/quotes/zigman/233680/quotes/nls/mdt MDT
+1.09% 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(R) (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 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(R) PC (Primary Cell), Activa(R) SC (Single Channel), and Activa(R)
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(R) 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.
SOURCE: Medtronic, Inc.
Medtronic, Inc.
Public Relations:
Melicent Lavers-Sailly, 905-460-3681
or
Donna Marquard, 763-526-6248
or
Investor Relations:
Jeff Warren, 763-505-2696
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