FDA allows marketing of first device to relieve migraine headache pain
The U.S. Food and Drug Administration has approved marketing of the Cerena Transcranial Magnetic Stimulator (TMS), a prescription device used to alleviate pain associated with migraine headaches preceded by a a visual sensory attack known as an aura, which affects about 33% of all sufferers.
Migraines are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound, and can last anywhere between 4-72 hours when untreated. They are also three times more common in women than men.
“Millions of people around the world suffer from migraines. This is the first device ever approved as a new treatment option for some patients,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
The Cerena TMS device is used by pressing it (with both hands) against the back of the head while the patient presses a button to release a magnetic energy pulse to stimulate the brain’s occipital cortex. However, it cannot be used by epileptics or anyone with a family history of seizures, or with any kind of metal implants in their heads, necks or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator.
Reported side effects from using the device reported during the clinical trials were restricted to one report each of sinusitis, aphasia (inability to speak or understand language) and vertigo.