Last Friday, FDA allowed marketing of Cerena TMS, the first medical device to relieve pain caused by migraine headaches that are 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 FDA's Center for Devices and Radiological Health ("CDRH").
A migraine is a chronic, neurological disorder characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Typically a migraine headache is unilateral (i.e., affecting one half of the head) and pulsating in nature, lasting from 2 to 72 hours. Migraines may be associated with nausea, vomiting, photophobia (increased sensitivity to light), phonophobia (increased sensitivity to sound), and migraine headache pain is generally aggravated by physical activity. Up to one-third of people with migraine headaches perceive an aura. An aura is a visual, sensory, or motor disturbance immediately preceding the onset of a migraine attack. Occasionally an aura can occur with little or no headache following it.
Cerena TMS, manufactured by eNeura Therapeutics ("eNeura") in Sunnyvale, California, is a prescription medical device used after the onset of pain associated with migraine headaches preceded by an aura. FDA reviewed Cerena TMS under an automatic class III designation (de novo) summary option. This option is an alternate pathway to classify novel devices of low to moderate risk that are "not substantially equivalent" to a legally-marketed predicate device. Devices that classified through the de novo process (and subsequently cleared as 510(k) type medical devices class I or II) may be marketed and used as predicate devices for future 510(k) submissions. Devices that are classified under class III otherwise require a premarket approval application ("PMA"), which is a most stringent type of medical device marketing application.
Cerena TMS's de novo classification approval / decision is so new that FDA has not posted it yet on the list, and eNeura has not updated its website with the new name. Currently, eNeura lists a Spring TMS Total Migraine System, which appears to be essentially the same device as Cerena TMS and was studied clinically in patients having migraine with an aura.
Cerena TMS is used by a patient holding the device against the back of the head while the user presses a button to release a pulse of magnetic energy that stimulates the occipital cortex in the brain. For patients having a migraine with an aura, this energy may stop or lessen the pain, as demonstrated in a randomized clinical trial of 201 subjects who had mostly moderate to strong migraine headaches preceded by an aura in at least 30 percent of their migraines. From these subjects, 113 reported treating a migraine headache once when the pain was occurring. eNeura provided FDA with an analysis of these 113 subjects and a control group that demonstrated 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 in the control. And after 24 hours, nearly 34 percent were pain-free compared to about 10 percent in the control. According to the study, however,
Cerena TMS dos not appear to be effective in relieving other associated migraine symptoms such as sensitivities to light and sound and nausea. The study utilized subjects 18 years and older and did not test the device for migraines without an aura or other types of headaches. Some of the adverse events reported for using Cerena TMS included dizziness, and both the device and control subjects reported rare and single reports of sinusitis, aphasia (inability to speak or understand language), and vertigo (spinning sensation).
According to the FDA-permitted use for Cerena TMS, patients must not use Cerena TMS if they have metals in the head, neck, or upper body that may be attracted by a magnet, or if they have an active implanted device, for example, a pacemaker or deep brain stimulator. Cerena TMS also should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. In addition, Cerena TMS should not be used for more than one treatment in 24 hours.