FLAGSTAFF, Ariz.—JUNE 8, 2016—W. L. Gore & Associates (Gore) today announced the GORE® TAG® Thoracic Device family has exceeded 100,000 devices distributed worldwide. Built on more than 18 years of success in both clinical studies and real-world commercial use, this GORE TAG Thoracic Device family is the first in the market to reach this significant milestone.
The latest in a series of “firsts” for this thoracic stent-graft family, this milestone continues to underscore Gore’s commitment to advancing endovascular aortic repair therapies.
- First to receive CE mark in Europe – 1998
- First to obtain FDA approval - 2005
- First to obtain approval in Japan - 2008
- First FDA approval for isolated lesions including traumatic transections* - 2012
- First FDA approval for aneurysms, transections, and all Type B dissections - 2013
- First to reach 100,000 devices distributed – 2016
As the market-leading thoracic endovascular (TEVAR) treatment solution in the U.S. since 2011, the Conformable GORE TAG Device is indicated in most geographical regions for aneurysms, isolated lesions including traumatic transections, and Type B dissections. Designed to offer a thoracic endovascular treatment option, the GORE TAG Devices offer a less-invasive alternative to conventional therapy. The stent-graft family has demonstrated reduced operative mortality and morbidity, providing patients with a safe and effective alternative to open repair treatments.**
“Physicians desire a singular device with proven results and durability across all etiologies. Gore is always responsive to finding clinical and practical solutions for our practice,” said Mark A. Farber, MD, vascular surgeon (aortic specialist), Chapel Hill, North Carolina. “The magnitude of reaching such a large milestone exemplifies the adoption of the Conformable GORE TAG Device as the standard of care in TEVAR treatment.”
Dr. Farber will speak to this achievement at the 2016 Vascular Annual Meeting during his presentation, “Durable TEVAR: Results from 100,000 GORE TAG Thoracic Devices distributed worldwide,” on Friday, June 10 at 1:00 pm EDT Click here for more details.
The GORE TAG Device family is the most studied thoracic stent-graft available. Since the first clinical implant in 1998, the GORE TAG Thoracic Device family has been studied in 10 U.S. Food & Drug Administration-consented clinical studies, one European clinical trial (ADSORB), and one worldwide registry (GREAT).
“Our thoracic stent-graft is the trusted solution for TEVAR procedures, with more than half of all physicians choosing the device for even the most complex cases,” said Ryan Takeuchi, aortic business unit leader at Gore. “This confidence has been built on our nearly two decades of working closely with physicians to evolve the device — pioneering thoracic endovascular aortic repair therapy and delivering conformability without compromise.”
The Conformable GORE TAG Device is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support team and educational offerings. Earlier this year, Gore announced it has also achieved 250,000 patients treated*** with the GORE® EXCLUDER® AAA Endoprosthesis, a minimally invasive treatment option for patients with abdominal aortic aneurysms (AAA), with a legacy of repositionability, durability, and patency.
For more information on Gore’s Aortic products, please visit www.goremedical.com/aortic.
*Conformable GORE TAG Device was approved in the U.S. for aneurysms in 2011
**Based on data provided in: W. L. Gore & Associates, Inc. GORE® TAG® Thoracic Endoprosthesis Annual Clinical Update. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2015. AS0089-EN2.
***Based on the number of GORE® EXCLUDER® AAA Endoprosthesis Trunk-Ipsilateral Legs distributed.
At Gore Medical, 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 U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984.
Products listed may not be available in all markets. GORE®, TAG®, EXCLUDER®, and designs are trademarks of W. L. Gore & Associates.