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First medical headband to prevent migraine headaches ok'd by FDA

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The FDA has given its green light for Cefaly, the first device as a preventative treatment for migraine headaches. It is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use before the onset of pain.

According to the National Institutes of Health, migraine headaches affect approximately 10% of the world’s population, and are more prevalent in women than men. Sufferers experience intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound, which can last anywhere from 4-72 hours if left untreated.

Cefaly is a small, portable, battery-powered, prescription device manufactured by STX-Med in Herstal, Liege, Belgium. It resembles a plastic headband worn across the forehead just above the eyes and atop the ears. Users position the device using a self-adhesive electrode. which applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve (associated with migraine headaches). They may then feel a tingling or massaging sensation in that spot.

“The device provides an alternative to medication for migraine prevention,” stated 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.”
The FDA evaluated the safety and effectiveness of the device based on data from 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 to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium, in which 53% of the patients were happy with the results.

Those who complained stated they “disliked of the feeling and did not want to continue using the device,” felt sleepy during the treatments, and headache after the treatment session. However, no serious adverse events occurred during either study. It should alos be noted that Cefaly is indicated for patients 18 years old and up, and should only be used once a day for 20 minutes.

For more information contact the FDA at 888-INFO-FDA

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