FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announced that it has received approval from the US Food & Drug Administration (FDA) to proceed with the Gore REDUCE* Clinical Study. The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multinational trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for Patent Foramen Ovale (PFO) closure in patients with a PFO and history of cryptogenic stroke or imaging confirmed Transient Ischemic Attack (TIA). Patients will be randomized to one of two treatment arms, either antiplatelet medical management alone or device closure of the PFO in conjunction with antiplatelet medical management. The primary endpoint is freedom from recurrent ischemic stroke, imaging confirmed TIA, or death due to stroke through 24 months post-randomization. The study sponsor is currently recruiting up to fifty investigational sites in the US and Nordic countries.
