FDA has approved the first medical device to prevent migraine headaches. The device called Cefaly is the first Transcutaneous Electrical Nerve Stimulation (TENS) device specifically authorized for use prior to the onset of pain.
Cefaly manufactured by STX-Med in Herstal, Leige Belgium is a small portable battery-powered prescription device consisting of a plastic headband worn across the forehead and ears. 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 device is indicated for patients 18 years of age and older and should only be used once a day for 20 minutes.
FDA reviewed the data for Cefaly through the de novo premarket review pathway, which is generally used for low to moderate risk medical devices that are not substantially equivalent to an already legally marketed device.
The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals experiencing more than two migraine headache attracts a month and not taking any medications to prevent migraines for three months prior to using Cefaly.
The 67 person study showed that users of Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. But the device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.
Also a patient satisfaction study was done that involved 2, 313 Cefaly users in France and Belgium. The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and were willing to buy the device for continued use.
The most commonly reported complaints were dislike for how it felt to wear the device, sleepiness during the treatment sessions, and headaches after the treatment session. However, no adverse events occurred during either study.