Gore Global Registry for Endovascular Aortic Treatment Enrolls 3,000 Patients

Midpoint findings to be released at 2015 Vascular Annual Meeting in Chicago

Flagstaff, Ariz. (June 18, 2015) — W. L. Gore & Associates, Inc. (Gore) announced that important updates from the Gore Global Registry for Endovascular Aortic Treatment (GREAT) will be presented today at the 2015 Vascular Annual Meeting. To date, more than 3,000 patients have been enrolled in GREAT, the largest “real world” endovascular registry which is actively monitored and audited to ensure data reported is accurate.

Data from patients previously enrolled in GREAT will be presented during a Vascular Live presentation by Ross Milner, MD, Professor of Surgery, Co-Director, Center for Aortic Diseases, and Associate Program Director, Vascular Surgery Fellowship at the University of Chicago Medical Center and Dennis R. Gable, MD, FACS, Chief of Vascular Surgery and Co-Director, Center for Thoracic Aortic Disease at Baylor Plano Heart Hospital and Texas Vascular Associates.

“The ability to track such a large number of patients over an extended period of time is something that clearly sets GREAT apart from other registries,” said Dr. Gable. “This sample will provide us with an unparalleled opportunity to measure patient successes and outcomes that help us make continued improvements in endovascular repair of aortic disease.”

The presentation will highlight specific achievements and notable findings from GREAT, with a focus on data that supports the exceptional limb performance of the GORE® EXCLUDER® AAA Endoprosthesis. The GORE® EXCLUDER® Device limbs have a sutureless construction and fully supported stent designed to prevent kinking and occlusion. The presentation will feature a meta-analysis of several endovascular aneurysm repair (EVAR) devices that shows the GORE EXCLUDER Device limbs have the lowest incidence of occlusion at both one and three years. Additionally, 14.3 percent of GREAT patients had an aortic bifurcation of less than 16 mm and there have been no reported occlusions, compressions, fractures, migrations, or kinking. The presentation will also provide insight on how clinicians are effectively using the Conformable GORE® TAG® Thoracic Endoprosthesis to treat all Type B dissections. Through treatment of all Type B dissections there were no reported serious device events during the procedures and no migrations, fractures, or compressions.

“Device construction, materials, and stent design all have significant impact on the overall outcome of aortic procedures,” said Dr. Milner, National Co-Principal Investigator for GREAT in the US. “With more than 17 years of documented success, the GORE EXCLUDER Device demonstrates this importance with its proven track record of zero percent migration and fracture rates along with very low type I, III, and IV endoleak rates.”

GREAT is part of Gore’s dedication to post-market surveillance and monitoring long-term device performance in an effort to improve clinical practice and patient outcomes. Since August 2010, GREAT has collected data on patients treated with the minimally invasive GORE® TAG® Thoracic Endoprosthesis, Conformable GORE TAG Thoracic Endoprosthesis, GORE EXCLUDER AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis featuring C3® Delivery System 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. The registry tracks outcomes during patient treatment and post-treatment visits. In addition to procedural and clinical outcomes, data collected includes device used, treatment indication, patient demographics, and medical history.

“Improving patient outcomes is at the core of our collaboration with physicians,” said Ryan Takeuchi, Gore Aortic Business Leader. “GREAT is one way we can serve the global endovascular community by providing this incredibly valuable platform for analysis.”

ABOUT US

At Gore, we have provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 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.

GORE®, C3®, EXCLUDER®, and TAG® are trademarks of W. L. Gore & Associates.