The US Food and Drug Administration (FDA) issued a marketing clearance for eNeura Therapeutics’ Cerena transcranial magnetic stimulator (TMS), a device designed to relieve pain caused by migraines.
It is reportedly 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.
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Migraine headaches are characterised by intense pulsing or throbbing pain in one area of the head accompanied by nausea and vomiting and sensitivity to light and sound.
The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura.
Patients need to use both hands to hold the device against the back of their head and press a button so that the device can release a pulse of magnetic energy. This pulse stimulates the brain’s occipital cortex, which may stop or ease migraine pain.
FDA’s Center for Devices and Radiological Health Office of Device Evaluation director Christy Foreman said: "Millions of people suffer from migraines and this new device represents a new treatment option for some patients."
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By GlobalDataThe 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’s approval is based on a randomised control clinical trial involving 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30% of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present.
More than a 38% of people using the stimulator said they were pain-free two hours later, compared with 17% of patients who did not use the device.
Nearly 34% of device users said they were pain-free after 24-hours, compared to 10% of people who had not used the device.
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.
According to the FDA, the new device is approved only for use by those aged 18 or older, and should not be used by people with suspected or diagnosed epilepsy or a family history of seizures.
It should also not be used by anyone with any metal device implanted in the head, neck or upper body, or people with an active implanted medical device such as a pacemaker or deep brain stimulator.
The recommended daily usage of the device is not to exceed one treatment in 24 hours.
The FDA noted that there had been single cases of sinusitis, aphasia (inability to speak or understand language) and vertigo (sensation of spinning) in the device’s trials. Dizziness may be associated with the use of the device.
According to GlobalData estimates, the neuro-stimulation market in the US was valued at $1.82bn in 2012 and is expected to grow at a CAGR of 9.2% to reach $3.39bn by 2019.
