The Food and Drug Administration (FDA) has granted marketing clearance for eNeura’s single-pulse transcranial magnetic stimulation (sTMS) device for use in patients ≥12 years for the acute and prophylactic treatment of migraine.

sTMS is a non-invasive device that was initially cleared by the FDA in 2017 for acute and preventive treatment of migraine in adults. Approval in younger patients was partly supported by data from the ESPOUSE Study.

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“Until now, children have had very few safe and effective options for the treatment and prevention of migraine. Typically, migraine patients, including children, have had to use combinations of pharmaceutical products, each with potentially unpleasant and often disabling side effects, to prevent headache and treat acute headache attacks,” stated Dr David K Rosen, President and CEO of eNeura.

The device is placed at the back of the patient’s head where a forced magnetic pulse is delivered to treat an acute attack or to prevent a future migraine onset. The sTMS technology induces a mild electric current that can depolarize neurons in the brain. This mechanism is thought to interrupt the brain hyperactivity associated with migraine.  Clinical data have shown the device to be comparable in efficacy to migraine medications.

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sTMS is a portable, prescription-only device.

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