SpringTMS, Migraine Treatment Device Cleared by FDA

eNeura announced that the FDA has approved SpringTMS, a migraine treatment device designed for patient use, for the acute treatment of pain associated with migraine headache with aura.

SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. The device is placed at the back of the head where a focused magnetic pulse is generated by the push of a button.

In December 2013, eNeura received FDA approval of its first-generation transcranial magnetic stimulation device, Cerena. The FDA reviewed a double-blind, placebo-controlled, randomized clinical study of 201 patients. The study demonstrated 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.

Spring TMS will be launched at a select number of specialist headache centers in the U.S.

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