New magnet device to treat migraines approved in US

The first device aimed at easing the pain of migraines with aura has been approved for use by the US Food and Drug Administration (FDA).
The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura, a visual, sensory or motor disturbance immediately precedes the onset of a migraine attack.
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.

"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 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 reviewed a randomised control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 per cent of their migraines.

Of the study subjects, 113 recorded treating a migraine at least once when pain was present. Analysis of these 113 subjects was used to support marketing authorisation of the Cerena TMS for the acute treatment of pain associated with migraine headache with aura.

The study showed that nearly 38 per cent of subjects who used the Cerena TMS when they had migraine pain were pain-free two hours after using the device compared to about 17 per cent of patients in the control group.
After 24 hours, nearly 34 per cent of the Cerena TMS users were pain-free compared to 10 per cent in the control group.

Migraine headaches are characterised 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 10 per cent of people worldwide and are three times more common in women than in men. About one third of people with migraines experience an aura, FDA said.
The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea. The device is for use in people 18 years of age and older.