he US Food and Drug Administration (FDA) today allowed marketing of the Cerena Transcranial Magnetic Stimulator(TMS; eNeura Therapeutics), the first device approved to relieve pain caused by migraine headache with aura.
“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 device is used by prescription after onset of pain associated with migraine with aura. Using both hands, the patient holds the device to the back of the head and, pressing a button, releases a pulse of magnetic energy that stimulates the occipital cortex, stopping or reducing the pain associated with this type of migraine.
“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,” the FDA statement notes.
They reviewed data from a randomized control clinical trial including 201 patients with mostly moderate to severe migraine headaches with auras preceding at least 30% of episodes. Of these patients, 113 recorded treating a migraine at least once when pain was present, and the analysis of these 113 patients was used to support the marketing authorization, the release said.
However, treatment was not associated with relief of other associated symptoms of migraine, including sensitivity to light or sound and nausea, the FDA adds. The device is for use in patients 18 years of age or older, and the study did not evaluate performance of the device in other types of headaches.
Adverse events reported with treatment were rare in both device and control groups, the FDA release said, but included single reports of sinusitis, aphasia, and vertigo. “Dizziness may be associated with the use of the device,” the agency adds.
The device should not be used in patients who have metals in the head, neck, or upper body; who have an implanted medical device such as a deep brain stimulator or pacemaker; or those who have suspected or diagnosed epilepsy or a personal or family history of seizures, the FDA statement said.
“The recommended daily usage of the device is not to exceed 1 treatment in 24 hours,” it concludes.