Flagstaff, AZ (December 12, 2008)—W. L. Gore & Associates (Gore) today announced that Rush University Medical Center (Chicago, Illinois) is the first medical center to enroll a patient in the Gore REDUCE Clinical Study*. This milestone was achieved by the site's study co-investigators, Ziyad Hijazi, MD, Director of the Rush Center for Congenital and Structural Heart Disease and Professor of Pedatrics and Internal Medicine, and Vivien Lee, MD, Stroke Neurologist.
"Rush University Medical Center is honored to be the first site to enroll a patient in the Gore REDUCE Clinical Study," said Dr. Hijazi. "The reported experience with the device thus far from Europe has proven to be promising, so we are thrilled to be part of this multi-national trial which will help us further our understanding as to whether the GORE HELEX Septal Occluder significantly reduces recurrent embolic events as compared to medical treatment."
Dr. Vivien Lee added, "We are excited to be contributing to a trial that is geared toward determining whether there is a viable alternative to the current standard of care for the treatment of stroke patients."
The US Principal Investigators for the Gore REDUCE Clinical Study are John Rhodes, MD, Chief of Clinical Cardiology at Duke University Medical Center, and Scott Kasner, MD, Associate Professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center. The study is a prospective, randomized, multi-center, multi-national trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for PFO closure in patients with a PFO and history of cryptogenic stroke or imaging confirmed Transient Ischemic Attack (TIA). Patients 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 study sponsor is pursuing up to 50 participating investigational sites in the US and Nordic countries.
The GORE HELEX Septal Occluder was approved by the US Food and Drug Administration (FDA) last year for treatment of Atrial Septal Defect (ASD), a congenital heart defect. The GORE HELEX Septal Occluder is the first device of its kind to use ePTFE, a biocompatible material that allows progressive tissue ingrowth, to help seal the defect. The GORE HELEX Septal Occluder has been designed to be soft and flexible, conforming to the anatomy of the heart while bridging and covering the defect to stop the shunting of blood between the atria.
"The GORE HELEX Septal Occluder has proven its ability to treat ASD and we look forward to collecting data on its safety profile and efficacy for PFO," said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. "This multi-national trial will likely resolve the open debate about whether PFO closure is a viable option for treating cryptogenic stroke and TIA patients as compared to medical treatment alone, as it is used today."
* REDUCE: GORE HELEX Septal Occluder plus Anti-platelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed Transient Ischemic Attack (TIA) in Patients with Patent Foramen Ovale (PFO)
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 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 11th consecutive year. For more information, visit goremedical.com.
Erik Clausen or Shannon Murphy
Schwartz Communications, Inc. for W. L. Gore & Associates
415-512-0770
GoreMedical@schwartz-pr.com
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