First Device to Treat Migraine With Aura Approved
MONDAY, Dec. 16, 2013 -- The first device to treat migraine pain when the headache is preceded by an often-visual disturbance called an aura has been approved by the U.S. Food and Drug Administration.
The Cerena Transcranial Magnetic Stimulator (TMS) is held to the back of the head and the user presses a button to release a pulse of magnetic energy. This stimulates the brain's occipital cortex, which may reduce or eliminate migraine-associated pain, the FDA said in a news release.
The device was tested in a clinical trial of 201 people with mostly moderate-to-strong migraines. Nearly 38 percent of people with migraine pain were pain-free two hours after use, compared with 17 percent of people who didn't use the device, the FDA said. The device was not evaluated among people with headaches other than those with migraines preceded by aura, the agency said.
Among the rare side effects reported were sinusitis and dizziness. The device shouldn't be used by people with metals in the head, neck or upper body, or by people with an implanted medical device such as a pacemaker or deep brain stimulator, the FDA said.
The Cerena TMS is produced by eNeura Therapeutics, based in Sunnyvale, Calif.
The FDA has more about this approval.
Posted: December 2013