FDA Approves New Large-Diameter Tapered Designs of Gore TAG Conformable Thoracic Stent Graft

April 3, 2025—Gore & Associates recently announced an expansion of the Gore TAG conformable thoracic stent graft with Active Control system product line after FDA approval of four new large-diameter tapered designs: 34 x 28 mm, 37 x 31 mm, 40 x 34 mm, and 45 x 37 mm.

The company advised that the Gore TAG conformable thoracic stent graft with Active Control system, which was first approved in 2019, is indicated for endovascular repair of all lesions of the descending thoracic aorta, including aneurysms, transections, and type B dissections.

The company stated that the first United States commercial implantation with the new sizes was performed by Sukgu Han, MD, Chief of the Division of Vascular Surgery and Endovascular Therapy at the Keck School of Medicine of the University of Southern California in Los Angeles, California.

In Gore’s press release, Dr. Han commented that the new large-diameter tapers “provide a welcome addition to the available treatment options for patients and expand applicability for the existing Gore technology.”

Dr. Han continued, “The right device sizing is always critical and even more so when treating in a narrow true lumen. These additional tapered designs will help us achieve optimal sizing for a broader range of aortic diameters while continuing to leverage the proven performance and properties of this device system.”

He concluded, “The Gore TAG conformable thoracic stent graft with Active Control system is an outstanding technology. I found the device to perform with reliable conformability and controlled, staged delivery mechanism. And now I know that I have the sizes I need for more of the patients I need to treat.”