Medical technology company eNeura Inc reported on Wednesday the receipt of the new 510(k) clearance from the US Food and Drug Administration (FDA) to expand sTMS (Transcranial Magnetic Stimulation) indication to include children 12 years of age and older for the acute and preventive treatment of migraine.

Following this US FDA's clearance, the sTMS is now the only migraine product in the US indicated both for the acute and prophylactic treatment of migraine headache in adults and children (12 years of age and older).

According to the company, sTMS is a non-invasive, prescription-only device that utilises single-pulse Transcranial Magnetic Stimulation (sTMS) to induce a mild electric current that modulates nerve cells in the brain. This safe, non-invasive technology is believed to interrupt the brain hyperactivity associated with migraine. Treatment with the portable, patient-controlled sTMS device is painless, easy and takes just a few seconds.

The expansion of the label to include children 12 years of age and older was supported, in part, by the US FDA's review of the company's ESPOUSE Study, which was conducted in adult patients at eight leading US Headache Centres. Following a protocol of daily use, 46% of patients reported at least a 50% reduction in headache attacks.