FDA Approves Device For Migraine Pain
The FDA announced this month that the Cerena Transcranial Magnetic Stimulator by eNeura, a device used to alleviate migraine pain, has warranted their seal of approval and is now allowed to be marketed in the U.S. The device is the first of its kind to receive approval for this indication and is meant to be used on patients 18 years or older. Christy Foreman, Director of the Office of Device Evaluations, Center for Devices and Radiological Health of the FDA, stated “Millions of people suffer from migraines and this new device represents a new treatment option for some patients.”
According to the FDA, the device is an option only for those patients who experience migraine pain preceded by an aura. The device is used after the patient begins to feel onsets of symptoms. Using both hands, the device is held up to the back portion of the head and the user must press a button that will send bursts of magnetic pulses through the cranium stimulating the occipital cortex in the brain.
The device was presented to the FDA and reviewed under the NovoPremarket Review Pathway, a regulatory categorization for non-invasive medical devices that do not resemble devices already in use for the same indication. The trial used in the review consisted on 201 patients who experienced moderate to strong migraines. According to the study, 38% of the patients treated with the Cerena TMS device were relieved of pain within 2 hours, compared to 17% of those in the control group.
The study only focused on the alleviation of pain associated with migraine headaches, it did not evaluate pain relief in other types of headaches, nor did the study evaluate the effectiveness of the device on other symptoms associated with migraines such as nausea and sensitivity to light and sound.
There were some adverse effects reported with the use of the Cerena TMS device which included aphasia - the inability to speak or understand language. Vertigo, dizziness and sinusitis were also reported. According to the FDA, the device is not appropriate for people with foreign metals implanted in their heads, neck or upper body that are magnetic in nature. Those with pacemakers are also encouraged not to use this device as well as people diagnosed with epilepsy or with a familial history that includes epilepsy. The device is not suitable for users with a deep brain stimulator and should not be used more than once in a 24-hour period.
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm378608.htm