Enrollment Begins for Gore TAG Thoracic Branch Endoprosthesis LSA Feasibility Study

January 27, 2014—Gore & Associates (Flagstaff, AZ) announced commencement of the United States multicenter feasibility study of the Gore TAG thoracic branch endoprosthesis for the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery (LSA). The Gore TAG Thoracic Branch Endoprosthesis LSA Feasibility Study is being conducted under an investigational device exemption approved by the US Food and Drug Administration.

According to the company, the Gore TAG thoracic branch endoprosthesis is designed for long-term durability. The device allows for femoral-only access over a prepositioned branch guidewire for ease of implantation. The device also features the company’s Carmeda bioactive heparin surface for sustained antithrombotic bioactivity.

Himanshu Patel, MD, and David Williams, MD, enrolled the study’s first patient at the University of Michigan. In the company’s press release, Dr. Patel commented, “Thoracic aortic aneurysms that encroach on the LSA make treating these challenging anatomies very difficult, leaving physicians no choice but to use more invasive surgical techniques or to cover the branch vessel. Using the Gore TAG thoracic branch endoprosthesis, we were able to successfully treat the first patient in the study using endovascular means only. These results demonstrate the feasibility of using branched stent grafts to treat aortic aneurysms that involve the LSA.”

The study’s principal investigator, Michael Dake, MD, stated, “With this study, we hope to demonstrate that the Gore device allows physicians to safely treat aortic aneurysms near the aortic arch while maintaining blood flow to all branch vessels using endovascular techniques. Gore’s device will reduce the need for invasive surgical procedures commonly required today, thus reducing the complications associated with treatment of this complex disease.” Dr. Dake is Thelma and Henry Doelger Professor of Cardiovascular Surgery at the Stanford School of Medicine in Stanford, California.