FDA Approves Marketing of First Migraine Treatment Device

Marketing is now allowed for a device that serves as preventative treatment for migraines

The FDA has allowed the marketing of the first device for preventative migraine headache treatment, according to a press release from the FDA. The device, Cefaly, is the first transcutaneous electrical nerve stimulation (TENS) device authorized for use before the onset of migraine pain.

The FDA evaluated the safety of the device by using the results of a clinical study conducted with 67 individuals who experienced frequent migraine headaches. The study showed that those who used the device had “significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device.”

Cefaly is a portable, small, battery-operated prescription device that looks similar to a plastic headband and is worn across the forehead and above the ears. The user positions the device by using a self-adhesive electrode at the center of the forehead above the eyes. The device then applies an electric current to the skin and body tissue to stimulate the nerve that has been associated with migraine headaches. Patients 18 and over can use the device at a maximum of once per day for 20 minutes.

efaly 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, according to the press release. “This may help patients who cannot tolerate current migraine medications for preventing migraines.”

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