Flagstaff, Ariz. (June 2, 2016) — W. L. Gore & Associates, Inc. (Gore) today announced receipt of CE Mark for the GORE® EXCLUDER® Conformable AAA Device, a product designed for the treatment of abdominal aortic aneurysms (AAA) in patients with challenging anatomies. This device is the latest addition in Gore’s growing portfolio of innovative solutions for the endovascular treatment of aortic disease. Leveraging Gore's AAA device experience which has benefited more than 250,000 patients worldwide*, this new device builds upon a history unmatched by currently available stent-grafts.
Gore’s innovative EVAR solution expands on the legacy of repositionability, durability, and patency established by the GORE® EXCLUDER® AAA Device. As well, it incorporates stent design elements similar to the Conformable GORE® TAG® Device to enable apposition in tortuous aortas. Approved for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic neck length of 10 mm,** the new conformable AAA device allows for tailored treatment and crucial precision in more difficult anatomies.
“Before this approval, in order to qualify for EVAR, the patient had to fit a fairly narrow subset of anatomical criteria,” said Robert Rhee, MD, Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in New York. “The GORE EXCLUDER Conformable AAA Endoprosthesis will expand the applicability of EVAR to patients traditionally considered to have anatomy too challenging for endovascular treatment.”
The device introduces Gore’s Active Control System. This technology allows physicians to angle the device to optimize conformability and maximize seal in the proximal aortic neck.
“With the GORE EXCLUDER Conformable Device, our EVAR solutions will offer the broadest treatment range of any supplier in the market,” said Ryan Takeuchi, Aortic Business Unit Leader at Gore. “The feedback received on this new product suggests a high level of interest from physicians seeking to treat challenging AAA anatomies. As we scale up operations to meet this demand, we look forward to bringing this valuable product to patients and physicians.”
The GORE EXCLUDER Conformable 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. The comprehensive portfolio of products includes the first FDA approved off-the-shelf iliac branch device, the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. To round out the branched portfolio, studies are underway in the U.S. for the GORE® EXCLUDER® Thoracoabdominal Device and the GORE® TAG® Thoracic Branch Device.
* Based on the number of GORE® EXCLUDER® AAA Endoprosthesis Trunk-Ipsilateral Legs distributed.
** For use in patients with proximal aortic neck angles of up to 90 degrees with a minimum aortic neck length of 15 mm, and in patients with proximal aortic neck angles of up to 60 degrees with a minimum aortic neck length of 10 mm.
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 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®, EXCLUDER®, TAG®, and designs are trademarks of W. L. Gore & Associates.