First Patient Enrolled Into European Registry for Deep Brain Stimulation in Patients With Refractory Epilepsy

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Medtronic, Inc.

16 Mar, 2012, 08:00 GMT

MINNEAPOLIS and GENEVA, March 16, 2012 /PRNewswire/ --

Milestone comes 25 years after the first DBS implant for Tremor carried out in Grenoble, France

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.[1] 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".[2] 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[6] and a 10- year follow up study of DBS in Parkinson's disease led by the University of Toronto.[7]

"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 Hospital Geneva.

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.

About Medtronic

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.

References:

  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