Gore Reaffirms Commitment to Multi-National, Randomized Study on PFO Closure in Stroke Patients using GORE® HELEX Septal Occluder Versus Medical Management
W. L. Gore & Associates (Gore) today provided an update on the Gore REDUCE Clinical Study*, a prospective, randomized, multi-center, multi-national trial designed to demonstrate 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). The unique study, which includes up to fifty investigational sites in the U.S., Denmark, Finland, Norway and Sweden, is on track to meet its estimated completion in 2015. “In light of the recent press release regarding the preliminary results of CLOSURE I, we felt it important to re-emphasize our confidence in the design and expected outcome of the Gore REDUCE Clinical Study,” 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 remain very confident that the Gore REDUCE Clinical Study will ultimately achieve its intended objective. 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.”
According to Scott Kasner, MD, Professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, and U.S. Neurology Principal Investigator, “The design of the Gore REDUCE Clinical Study is unique from the other PFO stroke trials in several respects. 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. 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. These efforts will likely help resolve the open debate about whether PFO closure is a viable option for treating cryptogenic stroke / TIA patients as compared to medical treatment alone, as it is used today.”
The Gore REDUCE Clinical Study has several unique features: participation of Nordic investigational sites, 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. Recruitment in the Nordic countries, where patients may be more willing to be randomized, is projected to help drive study enrollment. Additionally, Gore is in the process of recruiting sites in the United Kingdom to participate in the Gore REDUCE Clinical Study. MRI will be used to evaluate all patients in the trial to more accurately confirm the presence of stroke and TIA. Additionally, the standardization of medical therapies across treatment arms will further aid the interpretation of the final results in assessing the potential benefit of device closure for the prevention of recurrent stroke.
The GORE HELEX Septal Occluder was approved by the U.S. Food and Drug Administration (FDA) in 2007 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.
*REDUCE: Gore® HELEX Septal Occluder plus Anti-platelet medical Management for Reduction of Recurrent Stroke or Imaging – Confirmed TIA in Patients with PFO.
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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 13th consecutive year. For more information, visit www.goremedical.com.
Products listed may not be available in all markets. GORE® and HELEX are trademarks of W. L. Gore & Associates. Starflex® is a trademark of NMT Medical.
Caution: GORE HELEX Septal Occluder is an investigational device, limited by United States Law to investigational use for the closure of PFO.
Indications for use in the U.S.: The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of ostium secundum ASDs. Indications for use under CE Mark: The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of ASDs, such as ostium secundum and PFO. Refer to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings, precautions and adverse events.