W. L. Gore & Associates (Gore) is announcing that Royal Sussex County Hospital in Brighton, is the first medical center in the UK to enroll a patient in the Gore REDUCE Clinical Study. The study is an FDA approved prospective, randomized, multi-center, international trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for 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 US and Europe. Today’s milestone was achieved by the site’s study investigator, David Hildick-Smith, MD, Director of Cardiac Research Unit, Brighton and Sussex University Hospitals.
“We are committed to reducing incidences of stroke. The enrollment of the first UK patient in the Gore REDUCE Clinical Study is a step in the right direction”
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, imaging confirmed TIA, or death due to stroke through 24 months post-randomization.
The US Food and Drug Administration (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 UK 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.
“We are committed to reducing incidences of stroke. The enrollment of the first UK patient in the Gore REDUCE Clinical Study is a step in the right direction,” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. “Due to our European experience regarding the clinical performance of the GORE HELEX Septal Occluder and our unique study design, we are confident in the completion of this study and the pursuit of an FDA indication for PFO closure and the prevention of recurrent stroke.”
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 14th consecutive year.
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