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FDA approves medical device to ward off migraines

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More than 37 million Americans suffer from migraine headaches, with women being affected three times more often than men. A new medical device may be effective for warding off migraine attacks for many of these sufferers. On March 11, the Food and Drug Administration (FDA) announced that it would allow marketing of Cefaly, which is the first medical device that has shown to prevent migraine headaches. In addition, Cefaly is first transcutaneous (via the skin) electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium. “Cefaly provides an alternative to medication for migraine prevention,” explained Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. She added, “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, which resembles a plastic headband worn across the forehead just above the ears. The user positions Cefaly 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; this current stimulates branches of the trigeminal nerve, which has been found to be related to migraine headaches. The user may feel a tingling or massaging sensation at the location of the electrode is applied. Cefaly is designed for individuals 18 years of age and older and should only be used once per day for 20 minutes.

The FDA reviewed Cefaly data via a premarket review pathway, which is a regulatory pathway for generally low- to moderate-risk medical devices that are not similar to an already legally marketed device. The effectiveness and safety of Cefalys was evaluated with a clinical study conducted in Belgium that comprised 67 subjects 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. In addition, a patient satisfaction study was conducted on 2,313 Cefaly users in France and Belgium.

The 67-person study compared users of Cefaly and a placebo device. It found that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used the placebo device. However, the device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study found that more than 53% of patients were satisfied with Cefaly treatment;; thus, they were willing to purchase 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. However, no serious adverse events occurred during either study.

Migraine is a throbbing type of headache, which is distinguished by the fact that symptoms other than pain occur with the headache. Nausea and vomiting, lightheadedness, sensitivity to light (photophobia), and other visual disturbances are common migraine symptoms. Migraines are also unique in that they have distinct phases. Not all individuals experience each phase, however. The phases of a migraine headache may include: Premonition phase: A change in mood or behavior that may occur hours or days before the headache; Aura phase: A group of visual, sensory, or motor symptoms that immediately precede the headache (i.e., hallucinations, numbness, changes in speech, and muscle weakness); Headache phase: Period during the actual headache in which throbbing pain occurs on one or both sides of the head (sensitivity to light and motion is common, as are depression, fatigue, and anxiety; Headache resolution phase: Pain lessens during this phase, but may be replaced with fatigue, irritability, and difficulty concentrating.