July 9, 2010 – W. L. Gore and Associates announced today that they are confident in the design and anticipated results of the Gore REDUCE Clinical Study, which was designed to test the safety and effectiveness of the Gore Helex Septal Occluder for patent foramen ovale (PFO) closure in patients with history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA). This prospective and randomized trial, which includes up to 50 investigational sites in the United States, Denmark, Finland, Norway and Sweden, is on track to be completed in 2015.
Stuart Broyles, Ph.D., associate with the Gore medical division stroke business, said that in light of the recent press release regarding the preliminary results of CLOSURE I, Gore officials wanted to re-emphasize their confidence in the design and expected outcome of the Gore REDUCE Clinical Study.
“Due to our European experience regarding the clinical performance of the GORE HELEX Septal Occluder and our unique study design, we remain very confident that the Gore REDUCE Clinical Study will ultimately achieve its intended objective,” Broyles said. “We are committed to the completion of this study and the pursuit of an FDA indication for PFO closure and the prevention of recurrent stroke.”
Scott Kasner, M.D., professor of neurology and director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, and U.S. neurology principal investigator, said there are several aspects that make the design of the Gore REDUCE Clinical Study unique from the other PFO stroke trials.
“First, magnetic resonance imaging (MRI) of the brain will be performed on all patients at baseline and at two years. This feature offers an additional imaging endpoint for making comparisons between the treatment arms,” Kasner said. “Second, it focuses on secondary prevention of stroke rather than TIA, which improves the reliability of the study outcomes and measurably impacts the public health. Finally, this is a multinational study, which enhances its global applicability.”
Kasner went on to say these efforts will likely help resolve the question of whether PFO closure is a viable alternative for treating cryptogenic stroke/TIA patients as compared to medical treatment alone.
Other features of the Gore REDUCE Clinical Study include:
• Participation of Nordic investigational sites, which is projected to help drive study enrollment;
• The use of imaging-confirmed stroke / TIA for assessing its primary endpoint;
• A 2:1 device to medical management randomization strategy;
• A standardization of medical therapies across treatment arms; and
• The use of the GORE HELEX Septal Occluder, which was approved by the U.S. Food and Drug Administration (FDA) in 2007 for treatment of atrial septal defect (ASD), a congenital heart defect.