by 
The united states Food and Drug Administration (FDA) announced last week it would allow the marketing of the magnetic device aimed at relieving migraine headache pain the very first time.
The FDA is green lighting eNeura to start marketing its Cerena Transcranial Magnetic Stimulator (TMS) because the first device to alleviate pain caused by migraine headaches that are preceded by a visual, sensory or motor disturbance. This kind of migraine headache affects about 10 percent of the population around the world, and it is three times more common in women compared to men.
The planet Health Organization ranks migraine within the top 20 causes of disability, and the National Headache Foundation estimates the problem costs the united states $24bn annually.
“Millions of people suffer from migraines and this new device represents a new treatment choice for some patients,” Christy Foreman, director of the Office of Device Evaluation within the FDA’s Center for Devices and Radiological Health, said inside a statement.
The Cerena TMS is a prescription device used after the onset of pain associated with migraines preceded by a feeling. The device requires individuals to use both of your hands to carry it from the back of their head while pressing a button to produce a pulse of magnetic energy to stimulate the occipital cortex in the brain.
The FDA reviewed a randomized controlled clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding a minimum of 30 percent of their migraines. The study showed nearly 38 percent from the subjects who used the Cerena TMS were pain-free 2 hours after while using device, when compared with about 17 percent of patients in the control group.
Cerena TMS wasn’t proven to help relieve migraine pain of these subjects who were experiencing symptoms for example sensitivity to light, sensitivity to sound and nausea. A few rare adverse events were reported during the study for both the tool and the control groups, including single reports of sinusitis, aphasia and vertigo. The FDA did say dizziness may be associated with the utilisation of the device.
“Patients must not make use of the Cerena TMS device if they have metals within the head, neck, or upper body that are attracted with a magnet, or if they have an energetic implanted medical device like a pacemaker or deep brain stimulator,” the FDA said.
The agency advised the device ‘t be utilized in patients with suspected or diagnosed epilepsy or perhaps a personal or family history of seizures.
