Flagstaff, Ariz. & London (April 28, 2015) — W. L. Gore & Associates (Gore) today announced that 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 first brachiocephalic treated patient in the 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.
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 this week at the Charing Cross (CX) International Symposium in London. The study represents Gore’s first use of a recent Food and Drug Administration (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.
“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.”
Currently, treatment of aortic arch aneurysms is 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, the GORE TAG Thoracic Branch Endoprosthesis offers a less invasive treatment option specifically designed for these challenging cases.
“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.”
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.
“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.”
Gore has met several other key milestones in its commitment to pursuing new clinical applications with its aortic branch and thoracic portfolio. In 2014, Gore initiated a clinical study evaluating the use of the GORE TAG Thoracic Branch Endoprosthesis for the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery (LSA). Gore also enrolled its first patient in the Gore Thoracoabdominal Aortic Aneurysm Clinical Study, which will assess the durable repair of aortic aneurysms encroaching on or involving visceral branch vessels using the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis. Enrollment in the Gore® EXCLUDER® Iliac Branch Clinical Study was completed in February 2015. Additionally, the FDA approved the Conformable GORE® TAG® Thoracic Endoprosthesis for the treatment of acute and chronic dissections in September 2013, making it the first stent-graft approved to treat aneurysms, traumatic transections, and Type B dissections of the thoracic aorta.
Visit the Gore aortic portal for additional information.
At Gore, we have provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US “100 Best Companies to Work For” lists since the rankings debuted in 1984.