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FDA Approves First Migraine Prevention Device

posted 19 Mar 2014, 07:57 by Mpelembe Admin   [ updated 19 Mar 2014, 07:58 ]

USA  Next Media -  The U.S. Food and Drug Administration has authorized the first nerve-stimulating device that can prevent the onset of migraines, according to a Wall Street Journal report.

Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health in a press release. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”

A migraine episode is characterized by painful throbbing in a portion of the head. Symptoms, which also include nausea, vomiting, and heightened sensitivity to light and sound, can last from four hours to as long as three days.

The prescription device, known as Cefaly, is a battery-powered electric nerve stimulation headband worn across the forehead and atop the ears. Michael Solomita, vice president of the device's North American distributor, Roxon Medi-Tech Ltd. of Canada, said the device is currently sold at retail in Canada for roughly US$300.

The technology reportedly has the ability to stave off migraine pains, which are transmitted by the trigeminal nerve from the scalp to the brain stem. The approved device emits low energy electric signals to the trigeminal nerve via an electrode placed on the forehead. These signals counteract pain signals travelling down the nerve.

The device maker suggests users suffering from migraines wear the headband 20 minutes daily, during which the FDA says patients will experience a slight tingling sensation on the forehead.

In a clinical trial held in Belgium that involved 67 migraine patients randomly assigned to treatment using the device or to take a placebo, patients using the headband experienced fewer days of migraines each month.

The treatment, however, was unable to completely alleviate migraines or reduce the intensity of migraine pains.

SOURCES: Cefaly, FDA, Wall Street Journal

http://www.cefaly.ca/#howitworks

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm

http://online.wsj.com/news/articles/SB10001424052702304020104579433921861863030


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