Gore TAG Thoracic Branch Endoprosthesis Gains FDA Approval

May 31, 2022—Gore & Associates recently announced United States FDA approval for its Gore TAG thoracic branch endoprosthesis (TBE). The device is indicated for the endovascular repair of lesions in the descending thoracic aorta while maintaining flow into the left subclavian artery (LSA) in select patients at high risk for LSA debranching procedures, the company said.

The pivotal study supporting FDA approval for the Gore TAG TBE enrolled 238 patients of varying pathologies of the descending thoracic aorta, including aneurysm, dissection, and traumatic transection. Michael Dake, MD, with the University of Arizona Health Services, and Himanshu Patel, MD, with the University of Michigan, served as Co-National Principal Investigators of the study.

“The Gore TAG TBE has the potential to simplify the treatment of zone 2 LSA revascularization because it is a single device that can be used in a single procedure,” commented Dr. Dake in the company’s press release. “The ability to endovascularly profuse the LSA plays a key role in minimizing surgical procedures and related risks.”

“The results of this study, which importantly measured both device technical success and the absence of select adverse events in zone 2 subjects, were very encouraging for a variety of patients across aortic pathologies,” added Dr. Patel.

Gore notes that it also has ongoing branch device studies in the United States and Brazil for its investigational Excluder thoracoabdominal branch device (TAMBE), including a United States pivotal trial under an investigational device exemption.

“As the first flexible, off-the-shelf, single-branch thoracic endoprosthesis for the aortic arch, the TBE device combines the proven conformability and durability of the Conformable Gore TAG device with the ability to endovascularly profuse the LSA,” said Eric Zacharias, Gore’s Medical Products Division Leader, in the company’s announcement. “This approval is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market.” 

Image courtesy of W. L. Gore & Associates.