eNeura has announced that it has received US 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 USA for the acute treatment of pain associated with migraine headache with aura.
SpringTMS is a prescription-only device that utilises single-pulse transcranial magnetic stimulation (sTMS) to induce very mild electrical currents that can depolarise 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, randomised clinical study of 201 patients. The study, which took place in 18 US centres, 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 US availability of SpringTMS will be launched at a select number of US specialist headache centres.
SpringTMS is currently CE marked in Europe and is available to patients in the UK for acute treatment of migraine. The UK 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 UK.
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, says, “The use of single pulse transcranial magnetic stimulation has given hundreds of patients in the UK relief from debilitating migraine without troublesome side effects. I am sure many migraine sufferers in the USA will also experience real benefits from this unique technology.”
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 comments, “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.”