The FDA allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
Migraine headaches 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. A migraine can last anywhere between four and 72 hours when untreated. These debilitating headaches affect approximately ten percent of people worldwide and are three times more common in women than in men. About one third of people with migraines experience an aura.
“Millions of people suffer from migraines and this new device represents 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 is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.
The FDA reviewed the data for the Cerena TMS through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
Adverse events reported during the study were rare for both the device and the control groups but included single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning). Dizziness may be associated with the use of the device.
Patients must not use the Cerena TMS device if they have metals in the head, neck, 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. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. The recommended daily usage of the device is not to exceed one treatment in 24 hours.
See the FDA Announcement
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability