FDA Approves First Device to Prevent Migraine

The US Food and Drug Administration (FDA) today allowed marketing of the first device for the preventive treatment of migraine headaches (Cefaly, STX-Med).It is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use before the onset of pain, the FDA noted in a statement released today."Cefaly provides an alternative to medication for migraine prevention," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."The device, which resembles a plastic headband worn across the forehead and over the ears, stimulates the trigeminal nerve using a self-adhesive electrode in the center of the forehead. "The user may feel a tingling or massaging sensation where the electrode is applied," the FDA notes. "Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes."The FDA reviewed 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.Two StudiesThe approval was based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than 2 migraine headache attacks a month and who had not ta...
Source: Psychology of Pain - Category: Psychiatrists and Psychologists Source Type: blogs