Medtronic Announces First Clinical Data on Occipital Nerve Stimulation for Chronic Migraine to Be Presented at American Headache Society Meeting
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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
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
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.