First Device Approved for Relieving Migraine Pain
The FDA announced the marketing approval of eNeura Therapeutic's Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura.
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.
Approval of the Cerena TMS was based on a randomized control clinical trial in patients (n=201) who experienced moderate to strong migraine headaches and who had auras preceding at least 30% of their migraines. The study showed that nearly 38% 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% of patients in the control group. After 24 hours, nearly 34% of the Cerena TMS users were pain-free compared to 10% in the control group. Analysis of 113 subjects was used to support marketing authorization of the Cerena TMS in adult patients for the acute treatment of pain associated with migraine headache with aura.
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. The device is for use in people 18 years of age and older. The study did not evaluate the device's performance when treating types of headaches other than migraine headaches preceded by an aura.
Certain patients are warned not to use the device. Patients with metals in the head, neck, or upper body that are attracted by a magnet, or those with active implanted medical devices such as a pacemaker or deep brain stimulator must not use the device. Also, patients suspected or diagnosed with epilepsy or have a personal or family history of seizures should not use the device.For more information call (408) 245-6400 or visit eNeura.com.