Non-Invasive Magnetic Device Approved by FDA for Migraine Tx
The FDA has approved a non-invasive magnetic device to treat migraine.
eNeura announced that the Food and Drug Administration (FDA) has cleared the SpringTMS device for the acute and prophylactic treatment of migraine headache.
The non-invasive SpringTMS device is placed at the back of the patient's head where a forced magnetic pulse is delivered to treat an acute attack or to prevent a future migraine onset. The single-pulse transcranial magnetic stimulation (sTMS) technology induces a mild electric current that can depolarize neurons in the brain. This mechanism is thought to interrupt the brain hyperactivity associated with migraine.
The FDA's clearance was based on review of the post-marketing ESPOUSE Study that included 132 patients with migraine. The data showed patients who followed the daily SpringTMS device protocol experienced an average reduction from 9 headache days/month to 6 headache days/month after treatment. Also, nearly half of study patients (46%) reported a 50% reduction in headache attacks.
No serious adverse events were reported during the study. SpringTMS is available by prescription only.
eNeura, Inc. Receives FDA Clearance for Use of SpringTMS® for Migraine Prevention [press release]. Baltimore, MD: eNeura newsroom. http://www.eneura.com/press_releases/eneura-inc-receives-fda-clearance-for-use-of-springtms-for-migraine-prevention/. Published September 7, 2017. Accessed September 19, 2017.