Early Feasibility Study Begins for Gore TAG Thoracic Branch Endoprosthesis to Treat Aortic Arch Aneurysms

April 28, 2015—Gore & Associates announced that the first brachiocephalic-treated patient was enrolled in the Gore TAG thoracic branch endoprosthesis early feasibility study. The United States–based study will assess the treatment of aortic arch aneurysms in which perfusion of the brachiocephalic or left common carotid artery is maintained through the branch device. The study represents the company’s first use of a recent United States Food and Drug Administration early feasibility study guidance to help patients gain access to breakthrough medical devices and maintain innovation of new technologies in the United States, noted Gore & Associates.

Michel Makaroun, MD, enrolled the first patient in the study. The study’s Principal Investigator, Michael Dake, MD, will give a presentation on the study at the Charing Cross International Symposium being held April 28 to May 1 in London, United Kingdom. 

In the company’s press release, Dr. Dake commented, “Over the course of my career, I have witnessed a sustained focus on the development of less invasive approaches to aortic arch aneurysms. This clinical trial represents a culmination of years of research and development, beginning with the custom fabrication of a device to meet a specific patient's anatomy and now reaching a more practical off-the-shelf solution, which I am confident will improve outcomes for patients.” Dr. Dake is Thelma and Henry Doelger Professor of Cardiovascular Surgery at the Stanford School of Medicine in Stanford, California.

Dr. Makaroun added, “Aortic arch aneurysms present physicians with a very difficult challenge, as no other approved endovascular method exists to treat this region. Working with Gore on this early feasibility study gives us the opportunity to explore the Gore TAG thoracic branch endoprosthesis as a potentially new less invasive treatment option that will greatly benefit this patient population.” Dr. Makaroun is Co-Director of the University of Pittsburgh Medical Center Heart and Vascular Institute and the Chair and Professor of Surgery, Division of Vascular Surgery at the University of Pittsburgh School of Medicine in Pittsburgh, Pennsylvania. 

According to the company, the TAG thoracic branch endoprosthesis is an off-the-shelf device with aortic and branch components constructed specifically for use in the arch. The device allows for femoral-only access over a prepositioned branch guidewire designed to minimize the risk of branch vessel coverage and improve ease of implantation. The branch device also features Gore’s CBAS heparin surface to provide improved thromboresistance within the branch component of the device.

The TAG thoracic branch endoprosthesis for aortic arch aneurysms is intended to be a less invasive treatment option for these challenging cases compared with the currently available treatments of either complex open surgical repair or hybrid procedures involving the combination of devices whose use in this application has yet to be approved by the US Food and Drug Administration and still requires a thoracotomy or incision of the sternum, advised Gore & Associates.