December 16, 2013
Magnetic Device To Treat Painful Migraines Gets FDA Approval
Lee Rannals for redOrbit.com - Your Universe Online
The FDA is green lighting eNeura to start marketing its Cerena Transcranial Magnetic Stimulator (TMS) as the first device to relieve pain caused by migraine headaches which are preceded by a visual, sensory or motor disturbance. This type of migraine headache affects about 10 percent of the population around the world, and it is three times more common in women than in men.
The World Health Organization ranks migraine in the top 20 causes of disability, and the National Headache Foundation estimates the condition costs the US $24bn a year.
“Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement.
The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. The device requires people to use both hands to hold it against the back of their head while pressing a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain.
The FDA reviewed a randomized controlled clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 percent of their migraines. The study showed nearly 38 percent of the subjects who used the Cerena TMS were pain-free two hours after using the device, compared to about 17 percent of patients in the control group.
Cerena TMS was not shown to help relieve migraine pain of those subjects who were experiencing symptoms such as sensitivity to light, sensitivity to sound and nausea. A few rare adverse events were reported during the study for both the device and the control groups, including single reports of sinusitis, aphasia and vertigo. The FDA did say 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 FDA said.
The agency advised that the device not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures.