First Patient Enrolled Into European Registry for Deep Brain Stimulation in Patients With Refractory Epilepsy
MINNEAPOLIS and GENEVA, March 16, 2012 /PRNewswire/ –
Milestone comes 25 years after the first DBS implant for Tremor carried out in
Medtronic, Inc. (NYSE: MDT) today announced that a patient from Kempenhaeghe-Heeze
(The Netherlands) is the first patient to be enrolled into the MORE (MedtrOnic Registry
for Epilepsy) Registry which is designed to look at the long-term efficacy, quality of
life impact and safety of deep brain stimulation (DBS) in patients with refractory
epilepsy. DBS for epilepsy received CE mark for use in Europe in August 2010. Medtronic
DBS 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.
The MORE Registry will involve approximately 200 prospective patients over two years
from more than 30 centres across Europe including the Tampere and Tubingen Hospitals which
have the most experience to date with DBS of the Anterior Nucleus of the Thalamus. The
primary objective of the registry is to examine the impact of DBS therapy on seizure
frequency. The study will also look at seizure type and severity, safety and impact of the
therapy on a patient’s quality of life.
More than 30% of people with epilepsy fail to gain control of seizures with
antiepileptic medications. These people are said to have refractory or drug resistant
epilepsy, which is defined by the International League Against Epilepsy (ILAE) as: “the
failure of adequate trials of two tolerated and appropriately chosen and used AED
(anti-epileptic drugs) schedules (whether as monotherapies or in combination) to achieve
sustained seizure freedom”. Currently, Medtronic DBS therapy is approved for use as
adjunctive (add-on) therapy for reducing the frequency of seizures in adults diagnosed
with epilepsy characterized by partial-onset seizures, with or without secondary
generalization, that are refractory to antiepileptic medications.
The MORE registry is the latest in a long history of research using Medtronic DBS
devices including three Level 1 studies of DBS for Parkinson’s disease, [3,4,5] one Level
1 study of DBS for Epilepsy and a 10- year follow up study of DBS in Parkinson’s
disease led by the University of Toronto.
“The MORE registry is important in increasing our understanding of how electrical
stimulation can help patients affected by refractory epilepsy. By studying the long-term
impact of DBS on the anterior nucleus of the thalamus, we hope to understand even further
how seizures can be controlled and reduced,” said Professor Paul Boon, Professor of
Neurology at the Department of Neurology, Ghent University Hospital in Belgium who is the
chair of the steering group behind the MORE Registry.
The commencement of the MORE Registry comes as the neuromodulation community
celebrates 25 years of DBS therapy. Professors Benabid and Pollak performed their first
DBS implant for tremor at the University of Grenoble in January 1986.
“It is amazing to think how far we have come since the first experimental implant of
deep brain stimulation for a movement disorder in the 1980s to today where the therapy is
now approved for conditions such as epilepsy and treatment-resistant obsessive-compulsive
disorder (OCD),” said Professor Pierre Pollak, Head of Neurology at the University
In Europe, Medtronic DBS Therapy has been CE mark approved for the treatment of tremor
since 1993, Parkinson’s disease since 1998 and primary dystonia since 2003. The first
approved implant of Medtronic DBS was carried out in 1993. More recently, Medtronic DBS
therapy has received CE mark approval for obsessive compulsive disorder (OCD) in July 2009
and most recently for refractory epilepsy in August 2010.
“Working with leading physicians, Medtronic helped pioneer deep brain stimulation, and
we continue to collaborate with leading researchers to advance DBS technology and research
next-generation therapies to treat chronic neurological conditions,” said Lothar Krinke,
Ph.D., vice president and general manager for the Deep Brain Stimulation business in
Medtronic’s Neuromodulation division.
About Medtronic Deep Brain Stimulation Therapy
More than 85,000 patients worldwide have received Medtronic DBS Therapy, which uses a
surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild
electrical pulses to precisely targeted areas of the brain. Electrical stimulation of
these areas normalizes the brain circuits that control symptoms. The stimulation can be
programmed and adjusted non-invasively by a trained clinician to maximize symptom control
and minimize side effects. 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.
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. To date more than 500,000 people
worldwide have received Medtronic Neuromodulation therapies.
Medtronic, Inc. (http://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. Actual results may differ materially from anticipated results.
1) Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342:314-9 2) http://www.ilae-epilepsy.org/visitors/Documents/Epigraph_Definitionofdrugresistantepilepsy.pdf (accessed 12th September 2010) 3) Deuschl et al. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. 4) Williams et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial. Lancet Neurol. 2010 Jun;9(6):581-91. Epub 2010 Apr 29 5) Weaver et al. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009 Jan 7;301(1):63-73. 6) Fisher R, Salanova V, Witt T, et al. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia, 51(5):906-907, 2010 7) Ten-year outcome of subthalamic stimulation in Parkinson disease: a blinded evaluation. Castrioto A, et al . Arch Neurol. 2011 Dec;68(12):1550-6. Epub 2011 Aug
SOURCE Medtronic, Inc.