FDA approves ‘Cefaly’ Device to Treat Migraine Headaches

Cefaly, a device that prevents migraine headache bagged approval of the Food and Drug Administration (FDA) to enter U.S. markets.

Manufacturer CEFALY Technology, Herstal in Belgiun, created the first migraine prevention device that works by transcutaneous electrical nerve stimulation or TENS. Cefaly are battery-powered with adhesive electrodes that can be placed on forehead like a pair of glasses. They reduce headache-induced pains and prevent migraine attacks by transmitting mild electric current to the endings of trigeminal nerves that are responsible for sensation in the face and functions like chewing and biting.

Many studies have been carried out since 2008 to measure the device's safety and efficacy. A randomized clinical trial conducted last year at five Belgian testing centers tested the device on 67 patients. During the three months observation, the participants wore the device daily for twenty minutes and it was found that their monthly migraine attacks reduced to two.

Nearly, 38 percent of participants who wore the device reported 50 percent reduction in episodes of migraine headaches. Almost 53 percent of the patients who were satisfied with Ceflay treatment were willing to purchase the device.

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

 FDA warns, Ceflay should be used by those who have prescrpition and are aged above and 18, their daily usage must not exceed more than 20 minutes. The data by the National Institute of Health reports nearly, 10 percent of worldwide population suffers from Migraine headaches and its prevalence is high among women than in men. The lightweight, easy to use and simple Cefaly devices offer better treatment of headaches compared oral medications and drugs.

Dr. Myrna Cardiel, clinical associate professor of neurology at New York University Langone Medical Center said, "This device is a promising step forward in treating migraine headaches, as it addresses an important part of what we believe triggers and maintains a migraine attack," reports HealthDay News.