Marketing Allowed for First TENS Device to Prevent Migraines

WASHINGTON — For the first time, the Food and Drug Administration is allowing marketing of a device as a preventive treatment for migraine headaches.

The transcutaneous electrical nerve stimulation (TENS) device, marketed as Cefaly, also is the first to be specifically authorized for use prior to the onset of pain.

“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.”

Resembling a plastic headband, Cefaly is a small, portable, battery-powered, prescription device. It is positioned in the center of the forehead, just above the eyes, using a self-adhesive electrode. An electric current applied to the skin and underlying body tissues stimulates branches of the trigeminal nerve, which has been associated with migraine headaches.

The device, manufactured by STX-Med in Herstal, Liege, Belgium, is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.

The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

Also used to prove safety and effectiveness was a clinical study conducted 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. Cefaly was shown to reduce days of migraines each month and to reduce the need for medication, compared to a placebo advice. The device did not completely prevent migraines, however, and did not reduce the intensity of migraines that did occur.

A patient satisfaction study of 2,313 Cefaly users in France and Belgium also was submitted, with more than  53% reporting satisfaction with Cefaly treatment and a willingness to buy the device for continued use. The most commonly reported complaints were dislike of the tingling sensation, sleepiness during the treatment session, and headache after the treatment session.

No serious adverse events occurred during either study, according to the reports.

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