International Study Examines Effectiveness of Gore Helex for PFO Closure in Patients With Cryptogenic Stroke
November 4, 2011 – W. L. Gore & Associates announced that Royal Sussex County Hospital in Brighton, United Kingdom, is the first medical center in the United Kingdom to enroll a patient in the Gore REDUCE clinical study. The study is a U.S. Food and Drug Administration (FDA)-approved prospective, randomized, multi-center, international trial designed to demonstrate safety and effectiveness of the Gore HELEX septal occluder for patent foramen ovale (PFO) closure in patients with a history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA). The unique study includes up to fifty investigational sites in the United States and Europe. This patient enrollment was achieved by the site’s study investigator, David Hildick-Smith, M.D., director of cardiac research unit, Brighton and Sussex University Hospitals.
“Royal Sussex County Hospital is honored to take part in this international trial with the hope of advancing treatment options for patients suffering from a history of cryptogenic strokes,” said Hildick-Smith.
Patients in the Gore REDUCE Clinical Study are randomized to one of two treatment arms, either anti-platelet medical management alone or device closure of the PFO in conjunction with anti-platelet medical management. The primary endpoint is freedom from recurrent ischemic stroke, TIA or death due to stroke through 24 months post-randomization.
The FDA approved the Gore HELEX septal occluder for treatment of atrial septal defect (ASD), a congenital heart defect, in 2006. The device received CE Mark for ASD and PFO closure in 1999. Participation in the Gore REDUCE Clinical Study by centers in the United Kingdom and Nordic countries is helping to drive enrollment in this pivotal trial.
The Gore HELEX Septal Occluder is composed of ePTFE material supported by a single-wire nitinol frame. Over the course of several weeks to months following implantation of the device, cells begin to infiltrate and grow over the ePTFE material, aiding in the successful closure of the defect.
For more information: www.goremedical.com
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