Private medical technology company eNeura announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its migraine treatment device SpringTMS. The device is the first device that is available to U.S. patients for the treatment of acute pain linked with migraine headache with aura.
SpringTMS is a prescription-only device that uses single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents intended to depolarize neurons in the brain. The activity is believed to interrupt the abnormal hyperactivity linked with the occurrence of migraine. SpringTMS is a non-invasive medical device designed for patient use. The device is simply placed at the back of the head where it generates a focused magnetic pulse with the push of a button.
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.”
The company first received FDA clearance in December 2013 for its first-generation transcranial magnetic stimulation device Cerena. The U.S. FDA approval was based on the review of a clinical study involving 201 patients. The study showed that almost 38 percent who used sTMS in the event of a migraine were pain-free after two hours compared to about 17 percent in the control group. After 24 hours, only 10 percent of the patients in the control group were free from pain compared to about 34 percent of patients who used sTMS. SpringTMS utilizes the same therapy as Cerena, only with improved portability.
Richard B. Lipton, 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 said, “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.” Professor Lipton said he anticipates the post-market observational study for SpringTMS to be conducted for patients in the U.S.
The U.K. National Institute for Health and Care Excellence (NICE) has published a positive recommendation for the device. SpringTMS is CE Marked in Europe and is available to patients in the U.K.