FDA Approves First Migraine-Preventive Medical Device

The US Food and Drug Administration has approved Cefaly, the first device as a preventive treatment for migraine headache. Manufactured by CEFALY Technology (formerly STX-Med) in Belgium, Cefaly is also the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of pain. Cefaly requires a prescription and is indicated only in adult patients 18 years of age and older. It should be used only once per day for 20 minutes.

Cefaly is a small, portable, battery-powered device that resembles a plastic headband worn across the forehead and atop the ears. The device is positioned in the center of the forehead just above the eyes using an adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which is associated with migraine headaches. There may be tingling or a massaging sensation where the electrode is applied.

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

The FDA reviewed the safety and efficacy data for Cefaly from a clinical study conducted in Belgium of 67 individuals who experienced more than 2 migraines per month and who had not taken any medications to prevent migraines for 3 months prior to using Cefaly. 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. Cefaly did not completely prevent migraines and did not reduce migraine intensity when they did occur.

A patient satisfaction study of 2,313 Cefaly users in France and Belgium was also evaluated. A little more than 53% of Cefaly users were satisfied with treatment and willing to buy it for continued use. The most common complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during treatment, and headache after treatment.