Milestone Achievement in Monitoring Patient Outcomes and Device Performance
FLAGSTAFF, Ariz - Wednesday, February 25th 2015 [ME NewsWire]
(BUSINESS WIRE) -- W. L. Gore & Associates, Inc. (Gore) reports that more than 2,500 patients have been enrolled in the Gore Global Registry for Endovascular Aortic Treatment (GREAT). The registry 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.
“What separates the Gore registry from other medical registries is the minimal exclusion criteria, unprecedented number of patients, and length of follow-up,” said 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. “The active tracking of long-term device performance and associated patient outcomes will provide key insights into real-world clinical practice, which is vital to advancing the future of endovascular repair and improving patient outcomes.”
GREAT is currently comprised of 2,511 patients at 84 sites in 13 countries and demonstrates the proven performance of the Gore product portfolio. The registry tracks outcomes during patient treatment and post-treatment visits for up to 10 years, providing longer-term follow-up than past prospective registries. In addition to procedural and clinical outcomes, data collected include device used, treatment indication, patient demographics, and medical history.
“GREAT demonstrates the collaborative dedication of physicians around the world to advance patient care,” said Piergiorgio Cao, MD, Chief of Vascular Surgery at San Camillo Forlanini Hospital, Rome, Italy. “We want to ensure that patients are receiving optimal treatment through safe therapies.”
To date, 80% of the GREAT procedures have been EVAR, 16% TEVAR, and 4% were other endovascular procedures. The most commonly treated pathologies have been abdominal aortic aneurysm (72%), iliac aneurysms (10%), descending thoracic aortic aneurysms (7%), and Type B dissections (3%).
GREAT investigators have consistently shared registry results through publication and presentations at professional and society meetings. The latest registry findings and outcomes will be presented at the 2015 Charing Cross International Symposium in April and Vascular Annual Meeting in June.
“GREAT exemplifies our dedication to advancing endovascular therapy and providing durable products for patients worldwide. Creating a collaborative environment for physicians to come together is a cornerstone of our commitment at Gore Medical,” said Ryan Takeuchi, Gore Aortic Business Leader.
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. For more information, visit www.goremedical.com.
GORE®, TAG®, and EXCLUDER® are trademarks of W. L. Gore & Associates.
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