U.S. FDA approves headband device for migraine prevention
By The Associated PressNews
March 12, 2014 — The U.S. Food and Drug Administration said Tuesday it approved a nerve-stimulating headband as the first medical device to prevent migraine headaches.
Agency officials said the device provides a new option for patients who cannot tolerate migraine medications.
The Cefaly device is a battery-powered plastic band worn across the
forehead. Using an adhesive electrode, the band emits a low electrical
current to stimulate nerves associated with migraine pain. Users may
feel a tingling sensation on the skin where the electrode is applied.
The device is designed to be used no more than 20 minutes a day by
patients 18 years and older.
A 67-person study reviewed by the
FDA showed patients using the device experienced fewer migraines per
month than patients using a placebo device. The Cefaly headband did not
completely eliminate migraine headaches or reduce the intensity of
migraines that occurred.
About 53 per cent of 2,313 patients in a
separate study said they were satisfied with the device and were
willing to purchase it for future use.
No serious adverse events were connected with the device.
Cephaly is manufactured by Cephaly Technology of Belgium.
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