And the winners of new Migraine treatments are… Migraineurs living in Europe and the United Kingdom
Those of us in the United States have been not-so-patiently watching for results of the clinical trials and awaiting any news of FDA approval of two types of devices for Migraine treatment - implantable nerve stimulators and transcranial magnetic stimulation. Yes, we’ve been waiting… and waiting… and waiting… while no approval has come. In the meantime, transcranial magnetic stimulation was approved in the European Union a couple of years ago, and St. Jude Medical has just announced that they have received the European CE Mark Approval for their Eon family of neurostimulators to treat intractable chronic Migraine.
Transcranial magnetic stimulation
The Spring Transcranial Magnetic Stimulation device by eNeura (the Spring TMS Total Migraine System) Credit: Thinkstock delivers a single millisecond magnetic pulse to interrupt the electrical activity associated with Migraine and cortical spreading depression and stop the Migraine. It has been approved in the European Union and in use in the United Kingdom for more than a year now.
Information about this device was presented at the European Headache and Migraine Trust International Congress in London recently. Of the patients for whom the device has been prescribed by a Migraine specialist in Great Britain:2
- 73% reported a reduction in or alleviation of pain.
- 63% reported an improvement in Migraine symptoms.
Migraine specialist and researcher Dr. Peter J. Goadsby commented:
"For the many migraine sufferers whose medicines just do not do the job, it is exciting to see such an innovative, novel approach to treatment that provides new optimism."2
Andy Bloor, a patient who participated in the clinical trials of the Spring TMS device, said:
"I suffer from chronic migraines. Put simply, for me the TMS device worked.
"The key for me was using the device quickly "” as soon as the migraine started. When I did, often on first use and always on subsequent uses, it stopped the migraine in its tracks.
"The plus of the device is it reduces my reliance on strong drugs like cocodamol (acetaminophen and codeine)."2
For many patients, one of the most attractive and important points about this device is that, unlike currently approved Migraine abortive options, it can be used even by those patients with a history of or risk factors for heart or stroke issues. Thus, patients who cannot currently use any of the approved abortive medications, see this device as an opportunity to finally have an abortive option available. Another plus is not having to worry about medication overuse headache when Migraines are frequent enough to require treatment several days a week. Unfortunately, the Spring TMS Total Migraine System is not yet approved by the FDA for use in the United States. You can see a video demonstration of the Spring TMS on the eNeura web site.
Credit: Thinkstock Over the last several years, we’ve been hearing a great deal about implantable occipital neurostimulators for Migraine prevention. There have been well publicized clinical trials that have caught our attention and engendered many discussions and questions.
These stimulators are small as you can see by this photograph of the Eon Mini Neurostimulator next to a silver dollar. The use of neurostimulators has been studied using the stimulators in more than one location. Occipital nerve stimulation (ONS) is possibly the most discussed. ONS involves delivering a small electrical charge to the occipital nerve to prevent Migraines and headaches in patients who have not responded to medications. ONS is not effective for all patients, and a trial of occipital nerve block injections is often a good indicator of ONS suitability for specific patients.
The stimulator unit, as seen in the photo, is implanted in an area with some flesh - the hip, shoulder, or other area decided upon by the doctor and patient - and lead wires are then threaded under the skin to the nerves to be stimulated. Some of the units have batteries that have to be replaced; some have rechargeable batteries.
Several clinical trials have been completed with neurostimulation for Migraine and chronic Migraine, some are underway, and others are currently enrolling. You can find information about one of the trials in Peripheral Nerve Stimulator for Chronic Migraine.
Although St. Jude Medical has received the European CE Mark Approval for their Eon family of neurostimulators to treat intractable chronic Migraine, no neurostimulators are approved by the FDA for the treatment of Migraine or chronic Migraine in the United States.
Summary and comments
There’s a difference in availability between the Spring TMS Total Migraine System and neurostimulators in the United States. Since the TMS device isn’t approved in the U.S. for any condition, it isn’t available at all in the United States. Since neurostimulators are FDA approved for other conditions, doctors can recommend them off-label for Migraine.
This doesn’t necessarily mean that the stimulators will be covered by medical insurance companies. Some will cover them; others will not, stating that they are “experimental.” When coverage is denied, appeals are sometimes successful, but not always. Given that the stimulators are not FDA approved, it is, unfortunately, often difficult to win these appeals.
FDA has an enormous responsibility for public safety. Still, I have to wonder why it is that these devices are approved by the European Union, but not in the United States, the country in which they were developed. The need is easily demonstrable and is dire.
1 Press Release. “St. Jude Medical Receives European CE Mark Approval of Eon Mini Neurostimulator, the World’s Smallest Rechargeable Device to Treat Chronic Migraine.” St. Jude Medical. St. Paul, Minnesota. September 30, 2012.
2 Wylie, Catherine. “Portable device 'helped 73% of migraine sufferers.’” Irish Examiner. September 22, 2012.
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