Cefaly medical device receives FDA approval for migraine prevention

CEFALY Technology announced today that its received U.S. Food and Drug Administration (FDA) approval of the Cefaly® medical device for the preventative treatment for migraine headaches. Cefaly® is the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain. It is expected to be available in the U.S. in early April.

"The FDA approval of the Cefaly® medical device is a significant milestone for CEFALY Technology and for migraine patients across the United States," said Doctor Pierre Rigaux, the chief executive officer of CEFALY Technology, the Belgian maker and member of the inventors team of the Cefaly®. "It means for many episodic migraine sufferers preventative relief is just 20-minutes away."

Cefaly® is a plastic, battery-powered, device that resembles a headband and is affixed to the center of the forehead using a self-adhesive electrode that 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. Cefaly® is available by prescription-only and indicated for patients ages 18 and older. It should only be used once daily for 20 minutes. Women who are pregnant or could become pregnant should check with their doctor before using Cefaly®.

The FDA evaluated the safety and effectiveness of Cefaly® based on data from a clinical study 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®; as well as a patient satisfaction study of 2,313 Cefaly® users in France and Belgium.  

The 67-person study showed 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 patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment.

No serious adverse events occurred during either study. 

Cefaly® is patented in the U.S.

Cefaly® is also available in Canada and Europe.