2013年12月13日，美国食品药品监督管理局发布公告，批准经颅磁刺激技术用于偏头疼的治疗。
FDA NEWS RELEASE
For Immediate Release: Dec.13, 2013
Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
En Español
FDA allows marketing of first device torelieve migraine headache pain
TheU.S. Food and Drug Administration today allowed marketing of the CerenaTranscranial Magnetic Stimulator (TMS), the first device to relieve pain causedby migraine headaches that are preceded by an aura: a visual, sensory or motordisturbance immediately preceding the onset of a migraine attack.
Migraineheadaches are characterized by intense pulsing or throbbing pain in one area ofthe head accompanied by nausea and/or vomiting and sensitivity to light andsound. A migraine can last anywhere between four and 72 hours when untreated.These debilitating headaches affect approximately 10 percent of peopleworldwide and are three times more common in women than in men. About one thirdof people with migraines experience an aura.
“Millionsof people suffer from migraines and this new device represents a new treatmentoption for some patients,” said Christy Foreman, director of the Office ofDevice Evaluation in the FDA’s Center for Devices and Radiological Health.
TheCerena TMS is a prescription device used after the onset of pain associatedwith migraine headaches preceded by an aura. Using both hands to hold the deviceagainst the back of the head, the user presses a button to release a pulse ofmagnetic energy to stimulate the occipital cortex in the brain, which may stopor lessen the pain associated with migraine headaches preceded by an aura.
TheFDA reviewed the data for the Cerena TMS through the de novo premarket reviewpathway, a regulatory pathway for some low- to moderate-risk medical devicesthat are not substantially equivalent to an already legally marketed device.
TheFDA reviewed a randomized control clinical trial of 201 patients who had mostlymoderate to strong migraine headaches and who had auras preceding at least 30percent of their migraines. Of the study subjects, 113 recorded treating amigraine at least once when pain was present. Analysis of these 113 subjectswas used to support marketing authorization of the Cerena TMS for the acutetreatment of pain associated with migraine headache with aura.
Thestudy showed that nearly 38 percent of subjects who used the Cerena TMS whenthey had migraine pain were pain-free two hours after using the device comparedto about 17 percent of patients in the control group. After 24 hours, nearly 34percent of the Cerena TMS users were pain-free compared to 10 percent in thecontrol group.
Thestudy did not show that the Cerena TMS is effective in relieving the associatedsymptoms of migraine, such as sensitivity to light, sensitivity to sound, andnausea. The device is for use in people 18 years of age and older. The studydid not evaluate the device’s performance when treating types of headachesother than migraine headaches preceded by an aura.
Adverseevents reported during the study were rare for both the device and the controlgroups but included single reports of sinusitis, aphasia (inability to speak orunderstand language) and vertigo (sensation of spinning). Dizziness may beassociated with the use of the device.
Patientsmust not use the Crena TMS device if they have metals in the head, neck, orupper body that are attracted by a magnet, or if they have an active implantedmedical device such as a pacemaker or deep brain stimulator. The Cerena TMSdevice should not be used in patients with suspected or diagnosed epilepsy or apersonal or family history of seizures. The recommended daily usage of thedevice is not to exceed one treatment in 24 hours.
TheCerena TMS is manufactured by eNeura Therapeutics of Sunnyvale, Calif