Cefaly Technology has received FDA marketing approval for Cefaly, the first transcutaneous electrical nerve stimulation (TENS) device for the preventative treatment of migraine headaches. It is also the first TENS device specifically authorized for use prior to the onset of migraine pain.
A small, portable, battery-powered prescription device, Cefaly is worn across the forehead with a self-adhesive electrode. An electric current from the device is transmitted to the skin and underlying body tissues to stimulate trigeminal nerve branches, which have been associated with migraine headaches.
The FDA marketing 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. In the study, the device did not completely prevent migraine nor reduce the intensity of migraines that occurred, but patients did report fewer days with migraines per month and a reduced need for migraine medication compared to placebo. Fifty-three percent of the survey participants were satisfied with Cefaly treatment and were willing to buy the device for continued use. The review by the FDA was via the de novo premarket review pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
Cefaly is indicated for patients ≥18 years and should not be used more than once a day for 20 minutes.
For more information call (800) 361-6991 or visit Cefaly.ca.