Many readers have been emailing to ask about the electronic implant device they'd heard about for Migraines. Until now, not much information had been available. Now, Medtronic, Inc., reports a preliminary study. You can read the details below. Before you think you can run to your doctor and ask for this device however, keep in mind that this is a preliminary study. The implant is not approved for Migraine disease yet, and it is not available except to study participants.
MINNEAPOLIS, Sept. 28, 2004 - Medtronic, Inc. (NYSE: MDT), today announced
the first patient implant in a preliminary study to evaluate if an implanted
device might help some of the thousands of Americans who suffer the agony of
chronic Migraines that have not responded to other treatments.
Called Occipital Nerve Stimulation for the Treatment of Intractable Migraine, or
ONSTIM, the study involves a Medtronic Synergy® neurostimulation device, which
was implanted in a 47-year old female who has suffered from Migraines for 8
years. The neurostimulator delivers electrical impulses via insulated lead wires
tunneled under the skin near the occipital nerves at the base of the head.
According to
Joel Saper,
M.D., the ONSTIM study's principal investigator, and the founder and
director of the Michigan Head Pain and
Neurological Institute in Ann Arbor, Mich.,
"It is time to take a hard look at stimulation for chronic migraines. If stimulation proves to be as effective as we hope, it could help the large numbers of people who have failed to respond to currently available treatments."
The implant launched a prospective, randomized, blinded feasibility study, which will enroll participants at seven medical centers in the U.S. and one medical center in Europe. Medtronic received approval from the U.S. Food and Drug Administration (FDA) to conduct the study. Candidates for the study are adults who have had chronic Migraines which have persisted at least 15 days per month over three months and have been refractory to other treatments. Study patients first will receive stimulation from an external device to determine patient response. If adequate response is achieved, the Medtronic Synergy™ or Synergy Versitrel™ neurostimulator system will be implanted.
More than 32 million Americans - 70 percent of whom are women -- suffer Migraine attacks. According to the National Headache Foundation, Migraineurs lose about 157 million workdays each year. Many migraine sufferers progress to a chronic condition, experiencing Migraines more than 15 days per month. The majority of chronic migraine sufferers can be helped with medical measures that prevent attacks or treat them when they occur. However, Medtronic estimates that approximately 40,000 people in the U.S. do not respond to existing treatments, and many may be candidates for an alternative therapy.
"Occipital nerve stimulation may be a reasonable alternative to more invasive surgical procedures for treating chronic Migraine. This study is an important step forward in helping patients, many of whom have suffered in pain for years," said Richard L. Weiner, M.D., of Dallas Neurosurgical Associations in Dallas, Texas, who pioneered the procedure.
The first implant in this study was performed by Lesco Rogers, M.D., a colleague of Dr. Joel Saper at the Michigan Head Pain and Neurological Institute. "The study will also give us important information on the technique and use of the device in these patients. A new therapeutic approach would be welcomed for this unmet medical need," said Rogers.
Neurostimulation already has won wide medical acceptance for the management of symptoms of advanced Parkinson's disease along with such pain conditions as chronic back and leg pain and Complex Regional Pain Syndrome (CRPS).
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical
technology company, providing lifelong solutions for people with chronic
disease. Its Internet address is www.medtronic.com. Patients can obtain more information about
neurostimulation at (www.medtronic.com)
or by calling 1-800-510-6735.
