Mar 12, 2014 10:55 AM EDT
FDA Approves First Medical Device To Prevent Migraine Headaches
The U.S. Food and Drug Administration announced Tuesday that it approved a battery-powered plastic headband as a preventative treatment for migraine headaches, the Associated Press reported.
Cefaly is a nerve stimulating headband is the first medical device to prevent migraine headaches. It is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain, according to FDA officials.
"Cefaly provides an alternative to medication for migraine prevention," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
The headband is worn across the forehead. The band emits a low electrical current to stimulate nerves associated with migraine pain using an adhesive electrode. It is designed to be used no more than 20 minutes a day by patients 18 years and older, the AP reported.
Users may feel a tingling sensation on the skin where the electrode is applied.
The agency 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.
The device is designed for adults and should only be used once per day for 20 minutes, Foreman said.
Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound. A migraine can last from four to 72 hours when left untreated.
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