It is claimed to be the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain and this is also the first medical device to receive marketing approval in the US for the treatment for migraine headaches.
Cefaly is a small, portable, battery-powered plastic headband worn across the forehead with a self-adhesive electrode.
The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches.
FDA Center for Devices and Radiological Health director of the Office of Device Evaluation Christy Foreman said 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," Foreman added.
More severe than regular headaches, a migraine attack can last hours or even days, and may also include symptoms such as nausea, vomiting, and sensitivity to sound and light.
According to the National Institutes of Health, these debilitating headaches affect about 10% of global population and women are three times more likely to get them than men.
According to the agency, Cefaly is indicated for patients aged 18 years and above and should not be used more than once a day for 20 minutes.
The device offers patients suffering from migraine pain and headaches an efficient electrotherapeutical system delivered via an extremely comfortable, ergonomic and simple-to-use medical device.
The approval is based on a Belgian clinical study of 67 individuals and a patient satisfaction study of 2,313 Cefaly users in Belgium and France.
The patients reported fewer days with migraines per month and a reduced need for migraine medication compared to placebo. However, the device did not completely prevent migraine nor reduce the intensity of migraines that occurred.
The Cefaly medical device is available on the European market and in Canada.
