June 26, 2008
Medtronic Announces First Clinical Data on Occipital Nerve Stimulation for Chronic Migraine to Be Presented at American Headache Society Meeting
Medtronic, Inc. (NYSE: MDT) today announced that data from a multi-center, prospective, randomized, single-blinded, controlled investigational study using its neurostimulation system to stimulate the occipital nerves as a potential approach to treating medically refractory chronic migraines will be presented during a late-breaking session at the annual scientific meeting of the American Headache Society (AHS) tomorrow in Boston. This study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM), included patients who have regularly experienced 15 or more headache days per month that were not responsive to conventional medical therapies.
The ONSTIM study, sponsored by Medtronic and conducted under an investigational device exemption (IDE), collected electronic diary data from 66 patients from nine centers who were followed for three months. The data to be reported at the AHS meeting include the average change in the number of headache days per month, overall pain intensity and the responder rate based on at least a 50 percent reduction in headache days per month or at least a three-point reduction in overall pain intensity.
"The ONSTIM results suggest that occipital nerve stimulation, or ONS, may be a promising therapy option for individuals who have not had success in treating their chronic migraine and as a result are living with the painful and often debilitating symptoms," said Dr. Joel R. Saper, M.D., founder and director of the Michigan Head Pain and Neurological Institute, Ann Arbor, Mich., and principal investigator for the ONSTIM study. "While ONS for chronic migraine requires additional clinical evaluation, our early experience in this study is encouraging and indicates that ONS could possibly help some chronic migraine patients who have exhausted other treatment options."
In the study, thin lead wires were placed under the skin near the occipital nerves, which arise from the spinal cord and branch out across the back of the head carrying sensory signals from that region to the brain. The leads were connected to an implanted Medtronic neurostimulator that delivered controlled electrical pulses to the occipital nerves. Patients were randomized to three groups to receive: either a neurostimulator and have the ability to control the level of stimulation; or a neurostimulator as part of a device control group; or only standard medical management instead of an ONS implant. A positive response was defined as at least a 50 percent reduction in the number of headache days in a month, or a reduction in the pain intensity of at least three points on a standard 0-10 pain scale. In addition to evaluating the efficacy of ONS therapy, the ONSTIM trial was designed to follow patients out to three years related to safety.
"We are pleased to be the first to present randomized, controlled data on ONS for intractable chronic migraine, where there is a large unmet medical need not currently addressed by medication or other therapies," said Richard E. Kuntz, M.D., corporate senior vice president and president of the Neuromodulation business at Medtronic. "We plan to apply our expertise and long-standing history in neurostimulation for chronic pain to pursue additional studies of the ONS approach for those who suffer from these persistent and highly debilitating migraines."
As the pioneer in neurostimulation, Medtronic has experience in developing viable treatment options for thousands of people who suffer from chronic pain. Other Medtronic neurostimulation technologies already have gained significant medical acceptance for the management of symptoms of chronic back and leg pain, deep brain stimulation for the treatment of Parkinson's disease and essential tremor and sacral nerve stimulation for the treatment of the debilitating symptoms of overactive bladder.
About Chronic Migraine
More than 28 million Americans - 70 percent of whom are women - suffer from migraines and lose about 157 million workdays each year. Despite multiple drug treatments and noninvasive alternative therapies, approximately 3 - 14 percent of migraine sufferers progress to a chronic state and become intractable to medical therapies. Some of these patients could be candidates for ONS therapy if further studies demonstrate the safety and efficacy and lead to commercialization of this therapy.
In the United States, the total estimated annual cost of migraine headache is $17 billion. In the Global Burden of Disease Study, published by the World Health Organization in collaboration with the World Bank and the Harvard School of Public Health, severe migraine was ranked in the highest of seven disability classes along with psychosis, dementia and quadriplegia.
ONS for Chronic Migraine Presentation
Data on ONS for chronic migraine will be presented at the AHS meeting at the Marriott Boston Copley Place in Boston by Dr. Saper on Friday, June 27, 2008, at 3:30pm.
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 Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.