First device to prevent migraine headaches wins FDA approval

Date: Mar-12-2014The US Food and Drug Administration has given its first approval for the marketing of

a device for preventing migraine headaches. The federal agency says the device, which comes in

the form of a headband that delivers a nerve-stimulating low electrical current, may

bring relief to patients who cannot tolerate current migraine drugs.

"This is also the first transcutaneous electrical nerve stimulation device

specifically authorized for use prior to the onset of pain," they told the press.

The Cefaly device is a small, battery-powered plastic headband that is worn across the

forehead. The user attaches it with a self-adhesive electrode, just above the eyes. The device

delivers a low electric current through the skin and may cause a tingling or massaging

sensation. The current stimulates the trigeminal nerve, which has been associated with migraine

headaches.

The FDA has given its first approval for the marketing of a headband device that delivers nerve-stimulating low electrical current to prevent migraine headaches.

The device, which is manufactured by STX-Med in Herstal, Liege, Belgium, and available on

prescription for patients aged 18 and over, should only be used once a day for 20 minutes, says

the Food and Drug Administration (FDA).

According to the National Institutes of Health, migraine headaches affect about 10% of people

worldwide and are more common in women than men. The debilitating pain, which can last from 4 up

to 72 hours, is felt as intense throbbing in one part of the head and is often accompanied by

nausea, vomiting and sensitivity to light and sound.

Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices

and Radiological Health, says:

"Cefaly provides an alternative to medication for migraine prevention. This may help patients

who cannot tolerate current migraine medications for preventing migraines or treating

attacks."

The FDA reviewed a study conducted in Belgium involving 67 people of who were having at least

two migraine attacks a month and who ceased taking migraine medication for the 3 months

leading up to the start of the trial.

The results showed that compared with patients using a dummy device, those using Cefaly

reported significantly fewer days per month with migraine headaches and using less medication.

However, Cefaly did not completely prevent migraine attacks and did not reduce their intensity

when they occurred.

The FDA also reviewed a patient satisfaction survey of 2,313 Cefaly users in France and

Belgium that found 53% were satisfied with the treatment and would buy it for further use.

No serious adverse effects were reported by users in either study. The most common complaints

that arose in the user survey included not liking the sensation of the treatment, not wanting to

continue using it, feeling sleepy during treatment and having a headache afterwards.

In December 2013, the FDA approved the first medical device for the

treatment of migraine headaches preceded with aura. The Cerena Transcranial Magnetic

Stimulator, which is also available on prescription only, is used after the pain of migraine preceded

with aura has started.

Written by Catharine Paddock PhD




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