FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announced full approval from the US Food and Drug Administration (FDA) for the Gore EMBOLDEN Clinical Study1. The Gore EMBOLDEN Clinical Study is a prospective, multi-center, non-randomized, single-arm study designed to evaluate the safety and efficacy of the GORE Embolic Filter for neuroprotection during carotid artery stenting (CAS) in patients at high risk for carotid endarterectomy. The primary endpoint is a composite major adverse event rate of death, stroke, and myocardial infarction at 30 days post-procedure.
