15 Jun FDA Clears Portable Migraine Treatment Device
The U.S. Food and Drug Administration recently cleared the handheld device, SpringTMS, for the treatment of acute migraine with aura.
SpringTMS, available by prescription, creates mild electrical currents that can depolarize neurons in the brain. Experts believe this action interrupts the abnormal hyperactivity associated with migraine. When treating themselves, patients simply hold the device at the back of their head and press a button.
SpringTMS is made by eNeura, a medical technology company based in Baltimore, Maryland. Late last year, the company received FDA clearance for another device, Cerena, which works with the same technology and is worn on the head like a crown. SpringTMS is smaller and more portable than that first generation device, eNeura officials say.
The FDA evaluated a clinical study of 201 patients when evaluating this device. The study showed that almost 38% of the people who used the device were pain free two hours after its use compared to approximately 17% of patients in the control group. Thirty-four percent of the participants were pain free after 24 hours compared to 10% in the control group.
Initially, SpringTMS will be available at a small number of headache centers on the East and West Coasts as part of an open label study. Over time, the device will become increasingly available.