FDA Allows Marketing of Anti-Migraine Device Cefaly

The U.S. Food and Drug Administration announced Tuesday that it has allowed marketing of an anti-migraine device called Cefaly. The device can be used as a preventive treatment for migraine-related headaches.

Migraines are recurring attacks of moderate to severe pain that causes a throbbing or pulsating effect, usually on one side of the head. A migraine attack can last for 72 hours if left untreated.

Nearly 12 percent of the U.S. population suffers from migraines and women are three times more likely than men to suffer from the condition. Research on migraine has showed that the condition could lead to brain damage.

"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 a news release. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."

The device- Cefaly- resembles a small headband. It is a small and battery-powered device that applies electric current to the skin. The current stimulates branches of trigeminal nerve, which is thought to be associated with migraine headaches.

Cefaly is currently recommended for people of age 18 or above. The device should be used only once per day for 20 minutes, FDA said in a statement. Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium.

Safety and efficacy for the device was evaluated via a study conducted on 67 people living in Belgium. The participants had two migraine attacks a month and weren't on any medications to prevent headaches. Researchers also looked at data from 2,313 Cefaly users in France and Belgium to assess patient satisfaction.

Data from the patient satisfaction study showed that over half (53 percent) of the participants were satisfied with the treatment and were willing to buy the device. Common problems of using the device were sleepiness during treatment and headache after treatment session.

Cefaly is also the first transcutaneous electrical nerve stimulation (TENS) device, which can be used before the migraine attack.