UK Enrollment Commences in International REDUCE Study of Gore's Helex Septal Occluder

November 1, 2011—Gore & Associates (Flagstaff, AZ) announced the beginning of United Kingdom enrollment in the multicenter, international REDUCE clinical study, which includes up to 50 investigational sites in the United States and Europe. Study investigator David Hildick-Smith, MD, enrolled the first patient in the United Kingdom at Brighton and Sussex University Hospitals.

According to the company, the prospective, randomized study is designed to demonstrate safety and effectiveness of the Gore Helex septal occluder for closure of patent foramen ovale (PFO) in patients with a history of cryptogenic stroke or imaging-confirmed transient ischemic attack. Patients in the study are randomized to one of two treatment arms: 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 transient ischemic attack, or death due to stroke through 24 months postrandomization. More information about the Gore REDUCE study is available on the company's Web site.

Gore stated that the Helex septal occluder is composed of expanded polytetrafluoroethylene material, which is supported by a single-wire nitinol frame. After implantation of the device, cells begin to infiltrate and grow over the expanded polytetrafluoroethylene material, aiding in closure of the defect. The device received US Food and Drug Administration approval for treatment of atrial septal defect in 2006 and European CE Mark approval for atrial septal defect and PFO closure in 1999.