FDA Clears Neuromodulation Device for Acute Migraine Pain | 合法醫療器材資訊網

2021年3月2日—TheRelivionsystem,fromNeurolief,isanadjustableheadsetthatdeliversmodulatedpulsesofelectriccurrentthroughadaptiveoutput ...

The US Food and Drug Administration (FDA) has cleared the first noninvasive multichannel brain neuromodulation system to treat acute migraine pain.

The Relivion system, from Neurolief, is an adjustable headset that delivers modulated pulses of electric current through adaptive output channels around the head to six branches of the occipital and trigeminal nerves.

It is Cloud-enabled and linked to a mobile phone app. The device is designed to learn over time and to provide personalized therapy for individual patients, the company says.

The FDA approved the Relivion system on the basis of a multicenter, prospective, randomized, double-blind, placebo-controlled trial involving 131 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura.

The study showed that 46% of patients who used the Relivion de...