The U.S. Food and Drug Administration (FDA) said Tuesday it has approved the marketing of a medical device as a preventative treatment for migraine headaches.
The FDA said in a statement that this is the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.
The device, to be marketed under the name Cefaly, is manufactured by STX-Med in Herstal, Liege, Belgium.
“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. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks. ”
Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears, the FDA said. The user positions the device in the center of the forehead, just above the eyes, using a self- adhesive electrode.
The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied, the agency said.
According to the FDA, Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.
The FDA said the approval was based on data from a clinical trial in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly.
The study found that those who used Cefaly experienced ” significantly fewer days” with migraines per month and used less migraine attack medication than those who used a placebo device, the agency said.
The approval was also based on a patient satisfaction study of more than 2,300 Cefaly users in Belgium and France, which showed that about 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use, it said, noting that no serious adverse events occurred during either study.