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.