Gore Receives FDA Approval for Breakthrough Endovascular Device in Complex Aortic Aneurysms

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis approval brings the first branched, all-in-one solution for patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms in patients with appropriate anatomy.

FLAGSTAFF, Ariz. (January 25, 2024) — W. L. Gore & Associates (Gore) announced FDA approval for the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE), the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

U.S. physicians have had limited options for treating patients with aortic aneurysms involving the visceral branch vessels. The current standard of open surgical repair is complex and associated with a high rate of mortality and morbidity. Existing options for a minimally invasive approach are limited to products not designed for this purpose or custom-built devices — when and if the patient’s anatomy qualifies them — which can delay treatment due to manufacturing time.

“Until now, endovascular treatment options were limited as alternatives to open surgical repair,” said Mark A. Farber, M.D., National Principal Investigator. “TAMBE is an innovative first step forward that enables us to provide care that’s both effective and timely for complex aneurysm repair.

TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk patients with pararenal aortic aneurysms (PAAA) of the aorta using an endovascular approach in which the physician guides the device through arteries in the groin and arm via small incisions. Using established imaging techniques, the physician deploys the device to seal off the aneurysm, allowing blood to flow directly through the endoprosthesis. 

Because the disease frequently spans adjacent visceral vessels, TAMBE has four built-in, pre-cannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen.

“At Gore, we continue to pioneer endovascular solutions for physicians and their patients,” said Willy Davison, Gore Global Aortic Business Leader. “We look forward to this new technology expanding our portfolio as it becomes available in the coming months.”

The modular TAMBE incorporates a newly designed aortic component with components of other commercially available devices including, GORE EXCLUDER Iliac Branch Endoprosthesis Iliac Branch Component, GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and the GORE EXCLUDER AAA Endoprosthesis Contralateral Leg Endoprosthesis. Together, these components create a complete off-the-shelf solution for minimally invasive endovascular repair.

Expected to become available in June 2024, TAMBE builds upon the proven performance of the GORE EXCLUDER Device family, which has been ¬used to treat over 450,000 patients. With over 25 years of worldwide clinical experience, the GORE EXCLUDER AAA Endoprosthesis is the most studied EVAR device, numbering more than 1,500 peer-reviewed publications to date. 

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

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.8 billion. gore.com

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GORE, Together, improving life, EXCLUDER, VBX and VIABAHN are trademarks of W. L. Gore & Associates. 231321450-EN JANUARY 2024