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FDA Approves First Device to Prevent Migraines

First TENS device specifically authorized for use prior to onset of pain

TUESDAY, March 11, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved the first device aimed at preventing migraines. The device, called Cefaly, is also the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of pain, according to the FDA.

Cefaly is a headband-like device that runs on a battery and sits across the forehead and over the ears and applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve. Cefaly is made by Belgium-based Cefaly Technology and is available by prescription only. The device is only indicated for use by adults and should only be used for 20 minutes per day, the FDA said.

The FDA said Cefaly's approval was based on the results of a clinical trial in Belgium involving 67 people who had more than two migraine attacks per month and who had avoided medications in the three months prior to trying the device. Compared to people using an inactive placebo device, people who used Cefaly had significantly fewer days spent battling migraines compared to nonusers. They also had less need for migraine medications, the FDA said. Approval was also based on a patient satisfaction study of more than 2,300 Cefaly users in Belgium and France. That study found that 53 percent of people who tried the device said they were satisfied with it and would buy one for continued use.

The cost of the device in the United States is not known yet, but it sells for about $300 in Canada, according to the company's Canadian website.

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