eNeura has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its SpringTMS migraine treatment device, a non-invasive, prescription-only device designed to relieve pain caused by migraine headaches that are preceded by an aura.
Using single-pulse transcranial magnetic stimulation, the SpringTMS device induces very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine.
A focused magnetic pulse is generated with a push of a button on the device that is placed at the back of the head, eliminating the pain of a migraine headache.
In December 2013, eNeura had obtained approval from the FDA for its first-generation Cerena transcranial magnetic stimulation device.
eNeura claims that SpringTMS provides the same therapy as the Cerena device but offers improved portability. The initial US availability of the device will be launched at a select number of US specialist headache centers.
The SpringTMS migraine treatment device had already received CE Mark approval in Europe and is available to patients in the UK for acute treatment of migraine.
eNeura president and CEO Dr David Rosen said that the FDA clearance of SpringTMS is a significant accomplishment for eNeura and a tremendous validation of its sTMS technology.
"We are excited to introduce this new treatment to patients in the US through our post-market open-label study with leading headache specialists. This strategy will ensure we approach the market in a manner that enables the best outcome for patients using our device," Rosen added.