A first patient has been treated W.L Gore’s GORE® TAG® Thoracic Branch Endoprosthesis Early Feasibility Study. The US-based study will assess the treatment of aortic arch aneurysms in which perfusion of the brachiocephalic or left common carotid artery is maintained through a branch device.
Treatment of aortic arch aneurysms has hitherto been performed either through complex open surgical repair or through hybrid procedures involving the combination of devices whose use in this application has yet to be approved by the FDA and still requires a thoracotomy or incision of the sternum. In contrast to these alternatives, Gore says its GORE TAG Thoracic Branch Endoprosthesis offers a less invasive treatment option specifically designed for these challenging cases.
Designed for long-term durability, the GORE TAG Thoracic Branch Endoprosthesis is an off-the-shelf device, which includes aortic and branch components constructed specifically for use in the arch. The device allows for femoral-only access over a pre-positioned branch guidewire designed to minimize the risk of branch vessel coverage and improve ease of implantation. The branch device also features the CBAS® Heparin Surface. This technology, used in many of Gore’s peripheral products, is intended to provide improved thromboresistance within the branch component of the device.
Principal Investigator of the study, Michael Dake, MD, Thelma and Henry Doelger Professor of cardiovascular surgery at the Stanford School of Medicine, will present on the study at this week’s Charing Cross (CX) International Symposium in London. The study represents Gore’s first use of a recent FDA early feasibility study guidance to help patients gain access to breakthrough medical devices in order to maintain innovation of new technologies in the US.
Michel Makaroun, MD, co-director of the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute and the chair and professor of surgery in the division of vascular surgery, enrolled the patient and said; “Aortic arch aneurysms present physicians with a very difficult challenge, as no other approved endovascular method exists to treat this region,” said Dr. Makaroun. “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.”
“Over the course of my career, I have witnessed a sustained focus on the development of less invasive approaches to aortic arch aneurysms,” said Dr. Dake. “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.”
“This feasibility study is a testament to our longstanding commitment to innovation in new products and pathways, and to bringing products to market quickly,” said Ryan Takeuchi, Gore Aortic Business Leader. “We are the first to investigate this indication with an off-the-shelf endovascular device. We are meeting this challenge using our aortic branch portfolio to address this new and rather difficult clinical application.”
Source: Business Wire