FDA Allows Marketing of First Device for Migraine Headache Pain

SUNNYVALE, CA — For the first time, the Food and Drug Administration is allowing marketing of a device to relieve pain caused by migraine headaches that are preceded by an aura.

The device, the Cerena Transcranial Magnetic Stimulator (TMS), is manufactured by eNeura Therapeutics of Sunnyvale, CA. The recommended daily usage of the device is not to exceed one treatment in 24 hours.

The FDA noted that the debilitating headaches affect approximately 10% of all patients and are three times more common in women than in men. About one-third of patients 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.

A de novo premarket review pathway, reserved for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device, was used to approve Cerena TMS.

Supporting marketing authorization of the device was a randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30% of their migraines. Nearly 38% of subjects who used the Cerena TMS for migraine relief were pain-free two hours after using the device, compared with about 17% of patients in the control group. The relief persisted for 24 hours for nearly 34% of the group using the device, compared with 10% of the control group.

The study did not show, however, that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound and nausea.

Neither was the device, which is designed for use in adults, evaluated for treating types of headaches other than migraine headaches preceded by an aura. The FDA said Cerena TMS should not be used by patients with metals in the head, neck or upper body that are attracted by a magnet, if they have an active implanted medical device such as a pacemaker or deep brain stimulator, or with suspected or diagnosed epilepsy or a personal or family history of seizures.

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