Baltimore, Maryland – eNeura Inc. officials announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpringTMS migraine treatment device. SpringTMS is the first medical device available to patients in the United States for the acute treatment of pain associated with migraine headache with aura.
SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. The non-invasive, proprietary device is designed for patient use. To treat, the device is placed at the back of the head where the push of a button generates a focused magnetic pulse with the intent to eliminate the pain of a migraine headache.
eNeura's first-generation transcranial magnetic stimulation device (Cerena™) received FDA clearance in December 2013. The FDA reviewed a double-blind, placebo-controlled, randomized clinical study of 201 patients. The study, which took place in 18 U.S. centers, showed that nearly 38% of subjects who used sTMS when they had migraine headache pain were pain-free two hours after using the device compared to approximately 17% of patients in the control group. After 24 hours, approximately 34% of the sTMS users were pain-free compared to only 10% in the control group. The treatment did not produce any device-related serious adverse events.
SpringTMS provides the same therapy as the Cerena device but offers improved portability. The initial U.S. availability of SpringTMS will be launched at a select number of U.S. specialist headache centers.
SpringTMS is currently CE Marked in Europe and is available to patients in the United Kingdom for acute treatment of migraine. The U.K. National Institute for Health and Care Excellence (NICE) recently published positive guidance recommending TMS for acute and preventative treatment of migraine for patients in the U.K.
Professor Peter Goadsby, chair of the British Association for the Study of Headache, and director of the National Headache Centre at King's College Hospital in London, said, "The use of single pulse transcranial magnetic stimulation has given hundreds of patients in the U.K. relief from debilitating migraine without troublesome side effects. I am sure many migraine sufferers in the U.S. will also experience real benefits from this unique technology."
Dr. David K. Rosen, president and CEO of eNeura, commented, "The FDA clearance of SpringTMS is a significant accomplishment for eNeura and a tremendous validation of our sTMS technology. We are very confident that SpringTMS will offer tremendous benefit to many migraine sufferers."
Rosen continued, "We are excited to introduce this new treatment to patients in the U.S. 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."
Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center at the Albert Einstein College of Medicine, and lead investigator on the Cerena pivotal efficacy study commented, "Many patients with migraine do not get adequate relief from available medications, prefer not to take them and sometimes overuse them. There is a great need for an effective drug-free acute treatment option for these patients. The low risk of side effects and the ease of use of the SpringTMS make it a viable option for many of my patients. I look forward to participating in the post-market observational study for this innovative technology."