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FDA Approves New Device to Treat Migraines

Update Date: Mar 12, 2014 10:08 AM EDT

People who suffer from migraines might have an answer. The United States Food and Drug Administration (FDA) has approved a new electronic device in the shape of a headband that can reduce the frequency of migraines. The nerve-stimulating device will be available for patients who cannot tolerate migraine medications.

"Cefaly provides an alternative to medication for migraine prevention," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health according to the agency's news release. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."

The FDA decided to approve the battery-operated device, called Cefaly after reviewing a study conducted on 67 people. The study discovered that patients who used the device reported fewer migraines than patients who used a placebo device. The headband, however, could not get rid of all migraine headaches or reduce the intensity of the headaches when they did occur. In a separate study, researchers asked 2,313 patients if they would buy the device in the future. 53 percent of them said yes and reported being satisfied with the product.

Cefaly, which is created by STX-Med in Herstal, Liege, Belgium, is a plastic headband that is worn on the head atop the ears. It works to stimulate the nerves tied to migraine pain by emitting a low electrical current. The band also uses an adhesive electrode to help emit the current. Depending on where the electrode is placed on the head, the patient can expect to feel a tingling sensation. So far no adverse side effects have been identified. The device can only be used for 20 minutes at most per day. It will be available for adults aged 18 and older.

Migraine headaches are identifiable by intense pulsing or throbbing pain that is concentrated in one particular area of the head. These headaches can also include symptoms such as nausea, vomiting and sensitivity to sound and light. Migraines typically last anywhere from four to 72 hours when left untreated. Roughly 10 percent of the world's population suffers from migraines, according to the National Institutes of Health (NIH).


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