Gore Receives Approval From FDA For Unique Patent Foramen Ovale Stroke Study

Main Category: Stroke
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 May 2008 - 3:00 PDT

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W. L. Gore & Associates (Gore) announced that it has received approval from the US Food & Drug Administration (FDA) to proceed with the Gore REDUCE* Clinical Study. The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multinational trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for Patent Foramen Ovale (PFO) closure in patients with a PFO and history of cryptogenic stroke or imaging confirmed Transient Ischemic Attack (TIA). Patients will be randomized to one of two treatment arms, either antiplatelet medical management alone or device closure of the PFO in conjunction with antiplatelet 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 currently recruiting up to fifty investigational sites in the US and Nordic countries.

The trial is unique based on the participation of Nordic investigational sites, the use of imaging confirmed stroke and TIA for assessing its primary endpoint, a 2:1 device to medical management randomization strategy, and the use of the GORE HELEX Septal Occluder. Recruitment of patients in the Nordic countries is projected to help drive study enrollment as patients in this region may be more willing to be randomized. Magnetic Resonance (MR) Imaging will be used to evaluate all patients in the trial to more accurately confirm the presence of stroke and TIA. The 2:1 device to medical management randomization strategy and characteristics of the device are also expected to help study recruitment.

The GORE HELEX Septal Occluder became widely available in the US in 2007 and is FDA approved for the treatment of Atrial Septal Defects (ASD), congenital heart defects that often involve young children. The device has been widely utilized for the closure of both ASD and PFO in Europe since 1999. The GORE HELEX Septal Occluder is the first device of its kind to use ePTFE, a biocompatible material that allows progressive tissue in-growth, 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 published experience from Europe of the GORE HELEX Septal Occluder for PFO closure is promising, and suggests a reduction in the number of recurrent events in those patients receiving the device. The device is particularly well-suited for this application due to its soft, flexible design that conforms to the patient's anatomy. The Gore REDUCE Clinical Study's unique features will help drive enrollment while additionally positioning Gore to draw clear conclusions about whether PFO closure with the GORE HELEX device significantly reduces recurrent embolic events as compared to medical treatment," said John Rhodes, MD, Chief of Clinical Cardiology at Duke University Medical Center, and US cardiology Principal Investigator.

According to Scott Kasner, MD, Associate Professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, and US neurology Principal Investigator, "The design of the Gore REDUCE Clinical Study is unique from the other PFO stroke trials in several respects. First, MR Imaging 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 and TIA patients as compared to medical treatment alone, as it is used today."

The Nordic Countries' Principal Investigators are Lars Sondergaard, MD, Cardiology Laboratory at Rigshopitalet in Copenhagen, Denmark and Lars Thomassen, MD, PhD, Department of Neurology at Haukeland University Hospital in Bergen, Norway. The Gore REDUCE Clinical Study is part of a series of stroke intervention studies that Gore is initiating which also includes the Gore EMPiRE** Clinical Study.

* REDUCE: GORE HELEX Septal Occluder plus Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed Transient Ischemic Attack (TIA) in Patients with Patent Foramen Ovale (PFO)

** EMPiRE: Embolic Protection with Reverse Flow Study of the Gore Neuro Protection System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy

About W. L. Gore & Associates

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.

Gore Medical Products Division