The U.S. FDA has cleared the eNeura Therapeutics’ Cerena Transcranial Magnetic Stimulator (TMS), making it the first device to relieve pain caused by migraine headaches that are preceded by an aura.
Anyone who suffers Migraine headaches knows all about the intense pulsing or throbbing pain in one area of the head accompanied by symptoms that may include nausea, vomiting and sensitivity to light and sound. These debilitating headaches can last up to 72 hours if untreated and affect approximately 10 percent of people worldwide. About one third of people with migraines experience an aura, a catch-all description of visual, sensory or motor disturbance immediately preceding the onset of a migraine attack..
The Cerena TMS from Californian device company eNeura Therapeutics, is specifically intended for use after the onset of pain associated with migraine headaches preceded by an aura. It works by releasing a pulse of magnetic energy, which stimulates the occipital cortex in the brain.
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 randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 percent 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 authorization of the Cerena TMS for the acute treatment of pain associated with migraine headache with aura.
The study showed that nearly 38 percent 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 percent of patients in the control group. After 24 hours, nearly 34 percent of the Cerena TMS users were pain-free compared to 10 percent in the control group.
While use of the device demonstrably shortened migraine duration, 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.
“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.