W. L. Gore & Associates, Inc. (Gore) today announced that more than 250,000 patients have been treated* with the GORE® EXCLUDER® AAA Endoprosthesis. The GORE EXCLUDER Device has become a trusted solution for clinicians around the world since receiving CE Mark in Europe in 1997 and FDA approval in 2002. This trust stems from a device design that has proven to be safe and effective for nearly two decades of implant experience.
"Since completing the initial clinical trial, we have made one modification to the GORE EXCLUDER AAA Endoprosthesis design by adding a low-permeability film layer to the graft," said Ryan Takeuchi, Aortic Business Unit Leader at Gore. "Requiring so few changes to the graft is unprecedented, yet we have strived to broaden the applicability and value to more patients by expanding the portfolio of sizes, reducing profile, and introducing an innovative, repositionable deployment system."
The GORE EXCLUDER AAA Endoprosthesis is a minimally invasive treatment option for patients with abdominal aortic aneurysms (AAA), designed with active infrarenal fixation and engineered to provide migration resistance. The device also features exceptional limb performance due to the unique combination of ePTFE graft material and fully supported, nested, nitinol stent design to prevent kinking and occlusion. A presentation at the 2015 Vascular Annual Meeting featured a meta-analysis of several endovascular aneurysm repair (EVAR) devices that showed the GORE EXCLUDER Device limbs have the lowest incidence of occlusion at both one and three years.**
Achieving several key milestones in its commitment to provide patients and physicians with the most complete portfolio of durable treatment options for aortic disease, Gore recently announced the first implant in the United States of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis. This initial feasibility study, which has FDA consent to enroll up to 10 patients, will assess the safety of the device implantation procedure in the treatment of aortic aneurysms encroaching on or involving visceral branch vessels. Furthermore, Gore is advancing its branched portfolio with the anticipated 2016 FDA approval of the GORE® EXCLUDER® Iliac Branch Endoprosthesis, as well as continued enrollment in various studies evaluating the GORE® TAG® Thoracic Branch Endoprosthesis for aortic arch aneurysms.
"Gore has funded long-term clinical trials to evaluate endovascular devices. These trial results are remarkably similar to government-funded randomized trials, and have established certain benefits of these minimally invasive therapies to improve the health of patients. Further, in the United States OVER trial, endovascular repair reduced total healthcare costs," said Jon Matsumura, MD, Professor and Chairman, Division of Vascular Surgery at the University of Wisconsin School of Medicine and Public Health and National Principal Investigator of the initial device clinical trial.
Gore is dedicated to post-market surveillance and monitoring long-term device performance in an effort to improve patient outcomes. With more than 3,000 patients enrolled in the Gore Global Registry for Endovascular Aortic Treatment (GREAT), data has been collected since August 2010 on patients treated with the GORE EXCLUDER AAA Endoprosthesis as well as the GORE® TAG® Thoracic Endoprosthesis, Conformable GORE TAG Thoracic Endoprosthesis, and most recently, the GORE® EXCLUDER® Iliac Branch Endoprosthesis. A total of 5,000 consecutive patients from up to 300 worldwide sites will be enrolled in the registry, and their treatment results will be tracked for 10 years.
* Based on the number of Trunk-Ipsilateral Legs distributed.
** Data on file.
ABOUT W. L. GORE & ASSOCIATES
At Gore, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US "100 Best Companies to Work For" lists since the rankings debuted in 1984.
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