eNeura’s SpringTMS filing follows the recent FDA clearance of CerenaTMS, the first medical device cleared by the FDA to treat migraines.
Sunnyvale, Calif. - eNeura Inc. filed a 510(k) with the U.S. Food and Drug Administration (FDA) for the SpringTMS transcranial magnetic stimulation (TMS) device. SpringTMS is a second-generation medical device based on eNeura's ground-breaking CerenaTMS, which recently received FDA clearance for the treatment of pain caused by migraine headaches preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack. SpringTMS is more patient-friendly and portable compared to the previous generation device, and is already CE Marked in Europe and available by prescription in the UK.
CerenaTMS was the first medical device to be cleared by the FDA to treat migraine and SpringTMS operates along the same principles. The user applies TMS to the back of the head using both hands and presses a button to generate a focused, single pulse of magnetic energy that treats the migraine headache non-invasively and without discomfort.
David K. Rosen, President and CEO of eNeura, commented, "As a company, our focus is to provide patients with innovative and effective TMS medical technologies. By filing a 510(k) with the FDA for SpringTMS we have completed the next step on the path to bringing our most advanced TMS device to patients in the US. SpringTMS provides more user-friendly features compared to CerenaTMS, including a more compact size and shape, better portability and greater ease of use for the patient. We are optimistic that the SpringTMS will launch in 2014, having the advantage of improving upon our FDA-cleared predicate device."
Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound. Migraine is three times more common in women than in men and affects more than 10% of people worldwide. About one third of migraine sufferers experience an aura at the onset of pain.