Gore’s Excluder TAMBE Approved by FDA to Treat Complex Aortic Aneurysms

January 25, 2024—Gore & Associates announced FDA approval for the Excluder thoracoabdominal branch endoprosthesis (TAMBE). The device is an off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta. The company expects the Excluder TAMBE to become available in June 2024.

According to Gore, the Excluder TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms of the aorta. The device uses an endovascular approach with established imaging techniques to deploy the device and seal off the aneurysm, allowing blood to flow directly through the endoprosthesis.

The company noted that because the disease frequently spans adjacent visceral vessels, TAMBE has four built-in, precannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen. The modular TAMBE incorporates a newly designed aortic component with components of other commercially available Gore devices to create a complete off-the-shelf solution for minimally invasive endovascular repair.

Mark A. Farber, MD, served as National Principal Investigator of the TAMBE pivotal trial. The findings from TAMBE supported the company’s application for FDA approval.

“Until now, endovascular treatment options were limited as alternatives to open surgical repair,” commented Dr. Farber in Gore’s press release. “TAMBE is an innovative first step forward that enables us to provide care that’s both effective and timely for complex aneurysm repair.”