WASHINGTON - The 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.
