The U.S Food and Drug Administration (FDA) today approved the marketing of Cefaly, a device marketed to provide drug-free preventative treatment for migraine headaches.
Cefaly is a transcutaneous electrical nerve stimulation (TENS) device that provides electrical stimulation to a user's head. As a sort of battery-powered portable headband the device produces an electrical current meant to stimulate the trigeminal nerve, which the FDA states has been linked to migraines. The agency suggests that consumers use the device for only 20 minutes once per day.
The FDA approved Cefaly marketing following a premarket review that found the device to be low- to moderate-risk and non-equivalent to an existing legal medical device. The agency also determined the device's effectiveness through a small clinical trial that found Cefaly to be associated with a reduced number of migraines per month for patients who experience them on a frequent basis. Contrary to how the device is marketed in other countries, however, Cefaly was not found to reduce the intensity of migraines and does not totally prevent migraines.
“Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of Device Evaluation at the Center for Devices and Radiological Health at the FDA. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
This announcement comes just months after the FDA approved another portable device for the treatment of migraines. That device, the Cerena Transcrania Magnetic Stimulator, uses magnetic pulses to the back of a users head to sometimes relieve migraine pain.
Image via Cefaly