Belgium-based Cefaly Technology has obtained US Food and Drug Administration (FDA) approval for its device for preventative treatment of migraine headaches.
It is claimed to be the first medical device to receive marketing approval in the US for the treatment for migraine headaches and it is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorised for use prior to the onset of pain.
Manufactured by STX-Med in Herstal, Liege, Belgium, Cefaly is a small, portable, battery-powered plastic headband worn across the forehead with a self-adhesive electrode.
Highly precise impulses are transmitted through the electrode to nerve endings of the upper branch of the trigeminal nerve, which have been associated with migraine headaches.
FDA Center for Devices and Radiological Health's Office of Device Evaluation director 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 around 10% of the global population, with women 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 a comfortable, ergonomic and simple-to-use medical device.
The FDA evaluated the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
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.
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 migraines or reduce their intensity of those that occurred.
Around 53% of participants in a patient satisfaction study were satisfied enough that they would purchase it for future use, though others complained they did not like the feeling while wearing it, felt sleepy or experienced headache after treatment. No serious adverse events occurred during either study.
The Cefaly medical device is currently available on the European market and in Canada.