eNeura has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its SpringTMS migraine treatment device, designed to relieve the pain caused by acute headaches that are preceded by an aura.
Using single-pulse transcranial magnetic stimulation (sTMS), the non-invasive device induces very mild electrical currents that can depolarise neurons in the brain. This process is expected to interrupt the abnormal hyperactivity associated with migraine.
The prescription-only device must be placed at the back of the head and generates a focused magnetic pulse that eliminates the pain of a migraine headache.
eNeura claims that the SpringTMS device provides the same therapy as its Cerena transcranial magnetic stimulation device, but offers improved portability.
The FDA approved the Cerena transcranial magnetic stimulation device in December 2013. Approval is based on the review of a double-blind, randomised clinical study of 201 patients at 18 centres in the US.
eNeura president and CEO Dr David Rosen said that FDA-clearance of SpringTMS is a significant accomplishment for the company.
"We are excited to introduce this new treatment to patients in the US through our post-market open-label study with leading headache specialists," Rosen said. "This strategy will ensure we approach the market in a manner that enables the best outcome for patients using our device."
The SpringTMS device obtained CE Mark approval in Europe and is available in the UK. In addition, it will be initially available at a select number of specialist headache centres in the US.