Expert review of medical devices
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Expert Rev Med Devices · Dec 2019
Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety.
Introduction: Noninvasive neuromodulation devices represent an emerging field in the acute treatment of migraine. High efficacy, favorable safety profile, good tolerability and low cost are important factors for the desired shift to non-pharmacological treatments. This will have the potential to improve the quality of life of people with migraine and reduce the risk for adverse events and medication overuse headache (MOH). ⋯ Post-hoc analyses suggest that the efficacy of REN is non-inferior to usual care in general and to acute pharmacological treatments specifically. Expert commentary: Nerivo™ integrates clinically meaningful efficacy with a high safety profile, satisfying a great unmet need in migraine acute care. The unique mechanism of action, in which the electrical stimulation is applied to peripheral nerves in the upper arm, permits the introduction of an innovative device with high efficacy and superior and improved usability aspects compared with acute pharmacological treatments and other approved devices.