|eNeura's Cerena TMS--Courtesy of eNeura|
It happened in December: The FDA granted de novo premarket approval to eNeura's Cerena Transcranial Magnetic Stimulator, a portable migraine-fighting device. The FDA noted in its approval announcement that it is the first device of its kind to win U.S. regulators' OK to treat migraine headaches caused by an aura: a visual or sensory disturbance that comes before a migraine hits hard.
Cerena TMS comes through a prescription and is designed for use after a migraine strikes. A patient holds the device against the back of the head and then presses a button that lets out a pulse of magnetic energy to stimulate the brain's occipital cortex. For many patients, it will alleviate pain.
California-based eNeura gained approval, in part, using data from a pivotal trial involving 201 patients. Out of the subjects with migraines, almost 38% were pain-free two hours after onset, versus 17% in the control group. Close to 34% of patients in the treatment arm stayed pain-free 24 hours later, compared to 10% in the control segment.
Before it gained FDA approval, Cerena TMS had already hit the market overseas. Entry into the large U.S. market could be crucial in the long term, offering a wider patient base. About 10% of people globally suffer from migraines, the FDA said.
FDA approves eNeura's brain-stimulation device to treat migraines