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First patient enrolled in GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis pivotal study

U.S. pivotal study will determine safety and effectiveness of modular device designed to be the first completely off-the-shelf endovascular solution for aortic aneurysms involving the visceral branch vessels

FLAGSTAFF, Ariz. (JULY 18, 2019) W. L. Gore & Associates, Inc. (Gore) today announced the first patient has been enrolled in a pivotal study of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, an investigational device. The fully endovascular procedure successfully repaired a Crawford type IV thoracoabdominal aortic aneurysm involving complex visceral branch vessels, including those supplying the kidneys, liver, stomach and intestines. The surgery was performed on July 8 by Mark Farber, M.D., Chief of Vascular Surgery at University of North Carolina and the National Principal Investigator of the pivotal study.

“Currently, treatment options for these patients include an invasive open surgery or the use of a physician modified or custom manufactured endovascular device, often without validation of stent compatibility,” said Dr. Farber. “The Gore device allowed me to treat this patient with a ready-made, durable, conformable and fully endovascular solution appropriate for complex pararenal and thoracoabdominal aortic aneurysms.”

The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is an investigational device with a modular design comprised of five components.  The device utilizes an investigational aortic component in combination with commercially available devices for the branch components (GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis), the distal bifurcated component (GORE® EXCLUDER® Iliac Branch Endoprosthesis), and the iliac components (GORE® EXCLUDER® Device Contralateral Leg Endoprosthesis), each of which are being further evaluated for compatibility in this study. Further, an optional thoracic component (GORE® TAG® Conformable Thoracic Endoprosthesis) may be used to obtain proximal extension. 

The device’s aortic, side branch and iliac components are designed to maximize patient fit and withstand the durability challenges of thoracoabdominal and pararenal aortic aneurysms. The conformable, kink-resistant side branch component features CBAS Heparin Surface. The investigational aortic component offers multi-stage deployment with proximal, distal and rotational repositionability to aid in branch vessel access and deployment accuracy.

“While thoracoabdominal aortic aneurysms constitute a low percentage of aortic aneurysms, the involvement of multiple vessels supplying the kidneys and visceral organs makes their repair one of the more challenging tasks in aortic surgery,” added Dr. Farber. “Less invasive endovascular solutions are currently limited to a combination of products from multiple manufacturers and used off-label, or patients must sometimes wait weeks or months before implantation of a custom-built device.”

The pivotal study follows an early feasibility study conducted in the United States and Brazil, which had first implants in 2014.

“Today marks important progress in our ability to provide patients with an advanced technological option for the treatment of thoracoabdominal and pararenal aortic aneurysms,” said Eric Zacharias, a vascular business leader at Gore. “Results from this pivotal study could help in obtaining approval from the FDA for this innovative solution to better address challenging aortic anatomies and provide physicians with an even more complete device portfolio for the treatment of aortic aneurysms.”

Gore’s growing family of endovascular products share a mission to effectively treat the full range of challenging aortic anatomies, backed by Gore’s highly rated clinical support team and educational offerings.* The comprehensive portfolio of products includes: the GORE EXCLUDER AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA);  the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System for the treatment of thoracic aneurysms, transections and Type B dissections; the GORE EXCLUDER Iliac Branch Endoprosthesis, the only FDA-approved off-the-shelf device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms; and the GORE® Molding & Occlusion Balloon for EVAR stent graft seal and temporary vessel occlusion challenges.

* For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

MEDICAL PRODUCTS DIVISION

Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use, and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians, and through this collaboration we are improving lives. www.goremedical.com

ABOUT W. L. GORE & ASSOCIATES

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3.5 billion. www.gore.com