NeuWire Medical Announces FDA IDE Approval for STROKE-REWIRE Pivotal Study in Chronic Ischemic Stroke

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DALLAS–(BUSINESS WIRE)–NeuWire Medical today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for STROKE-REWIRE, a pivotal study evaluating the ReWire Vagus Nerve Stimulation System in patients with chronic ischemic stroke and upper-limb dysfunction. The prospective, multicenter, randomized, sham-controlled study will enroll up to 135 participants across up to 12 U.S. clinical sites. Study initiation is expected in t

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