FDA Provides Expanded Clearance for Device to Treat Migraine in Children

The Food and Drug Administration (FDA) has granted new marketing clearance for a device that provides acute and preventive treatment of migraine to include children 12 years of age and older.

The technology (sTMS; eNeura, Inc., Baltimore, MD) is a non-invasive device that uses single-pulse transcranial magnetic stimulation to emit a mild electrical current that modulates nerve cells in the brain.

Patients place the device at the back of the head and push a button to deliver a focused magnetic pulse that is believed to interrupt brain hyperactivity associated with migraine. 

The new clearance was supported by the ESPOUSE study (NCT02357381), which was conducted in adult patients at eight headache centers in the US. Following a protocol of daily use, 46% of patients reported at least a 50% reduction in headache attacks. 

“Until now, children have had very few safe and effective options for the treatment and prevention of migraine,” said David K Rosen, DVM, president and CEO of eNeura, Inc. “Typically, migraine patients, including children, have had to use combinations of pharmaceutical products, each with potentially unpleasant and often disabling side effects, to prevent headache and treat acute headache attacks. sTMS is now labeled to address the entire spectrum of migraine with an easy-to-use device that, in multiple clinical studies, has proven to be safe and effective.”