The marketing of Cerena Transcranial Magnetic Stimulator (TMS) to relief migraine associated headache has been approved by U.S. Food and Drug Administration. A patient with migraine can experience severe and throbbing pain accompanied by nausea and vomiting lasting from 7 hours to 24 hours. Women are three times more sucesseptible of having migraine in comparison to males. It has been estimated that approximately 10% people in the world are living with migraine.
“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.
The Cerena TMS will be dispensed only when it will be prescribed by the physician. When the patient will use this device during migraine pain it will reduce the intensity of the pain by stimulating the occipital cortex in brain. This reduction in pain is totally dependent upon the magnetic energy that Cerena TMS uses.
FDA evaluated the data of clinical trials in which 201 patients with migraine were enrolled to approve Cerena TMS device.
“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.”
Source: FDA News Release
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