First Device to Alleviate Migraine Approved by the FDA for Marketing

The U.S Food and Drug Administration (FDA) has recently approved the marketing of Cerena Transcranial Magnetic Stimulator (TMS), the very first device that can help alleviate pain caused by migraine headaches, according to Gold Rush Cam.

Migraine headaches are typically preceded by visual, sensory or motor disturbance and are characterized by intense pulsing or throbbing pain in one area of the head. It may also be accompanied by vomiting and or nausea as well as sensitivity to light and sound. If untreated, migraine attacks may last for as long as 72 hours. Across the world, approximately 10 percent of the population suffers from the condition and the chances of acquiring it are much higher among women than men.

"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 is a prescription device that is used after the onset of pain associated with migraine headaches preceded by an aura. The user holds the device with two hands and places it against the back of the head. The user then presses a button that will release magnetic energy that will then stimulate the occipital cortex in the brain.

To ensure it viability, the FDA reviewed a randomized control clinical trial of 201 patients who suffered from mostly moderate to strong migraine headaches. The study showed that 38 percent of subject who used Cerena TMS were pain-free just after two hours compared to 17 percent of patients who were part of a controlled group. The Cerena TMS is manufactured by eNeure Therapeutics.