FDA Approves Magnetic Device for Migraine Treatment

The U.S. Food and Drug Administration recently approved the marketing of a magnetic stimulator device to treat migraine headaches.The Cerena Transcranial Magnetic Stimulator (TMS), produced by Sunnyvale, CA-based eNeura Therapeutics, specifically won de novo premarket approval for treatment of migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack. "Millions of people suffer from migraines and this new device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a news release.Here's how the Cerena TMS works: A headache sufferer uses both hands to hold the device against the back of the head. Pressing a button releases a pulse of magnetic energy to stimulate the occipital cortex in the brain. An FDA-reviewed study found that 38% of migraine patients who used the device reported no pain after two hours, versus 17% in the control group. After 24 hours, nearly 34 percent of the Cerena TMS users were pain-free; only a tenth in the control group experienced no pain. The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea.