First Device Designed for Endovascular Treatment of Aortic Arch Lesions
AUSTIN, Texas—On May 8, 2017, Cardiothoracic and Vascular Surgeons—in collaboration with Heart Hospital of Austin—became the first in Central Texas to enroll a patient in the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) pivotal study for the treatment of aortic arch disease. Mark Felger, M.D., a cardiothoracic surgeon and pivotal trial principal investigator with Cardiothoracic and Vascular Surgeons, and Mazin Foteh, M.D., a vascular surgeon with Cardiothoracic and Vascular Surgeons, treated the first patient enrolled in the study at Heart Hospital of Austin.
The objective of the study is to determine the safety and efficacy of the TBE in treating lesions of the aortic arch and descending thoracic aorta—including dissection, trauma, or aneurysm—while maintaining blood flow into a single aortic arch branch vessel. The TBE offers a less invasive treatment option specifically designed for these challenging cases.
“The TBE device provides a significant advancement for patients suffering from aortic arch disease, which is challenging to treat and manage,” Dr. Felger said. “This new technology allows us to provide a less-invasive treatment option for aneurysms and dissections of the aortic arch rather than traditional open heart surgery.”
Aortic arch disease has traditionally been difficult to treat. The options currently available for treatment require complex open surgery or hybrid procedures involving the combination of devices whose use in this particular clinical application has yet to be approved by the U.S. Food and Drug Administration (FDA).
The limited options for aortic arch disease patients is one of the reasons that the TBE is the first Gore device to receive the new FDA Expedited Access Pathway designation and among the first medical devices to receive this designation in the nation. This pathway is limited to certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening diseases and offer a meaningful patient benefit compared to existing alternatives.
“We continuously strive to reach a higher standard of cardiac care for our patients, and we are committed to providing the latest tools that allow doctors to treat challenging cases efficiently and safely using the least invasive methods,” David Laird, chief executive officer at Heart Hospital of Austin, said.
The TBE is the first off-the-shelf aortic branch device to participate in a pivotal study. The pivotal study includes up to 40 sites across the U.S.
Heart Hospital of Austin
Heart Hospital of Austin is part of St. David’s HealthCare, one of the largest health systems in Texas, which was recognized with a Malcolm Baldrige National Quality Award in 2014. Heart Hospital of Austin—home to one of the largest non-academic cardiovascular research programs in the world—is a 58-bed hospital with a comprehensive 24-hour emergency department, an advanced Executive Wellness Program, five operating rooms (ORs), including two hybrid ORs, three catheterization labs and two electrophysiology labs. It is one of the highest performing cardiovascular facilities in the nation, specializing in the diagnosis and treatment of cardiovascular disease. In conjunction with its parent campus, St. David’s Medical Center, Heart Hospital of Austin recently ranked among the top hospitals in the nation by earning a five-star rating by the Centers for Medicare and Medicaid’s (CMS) new Overall Hospital Quality Star Rating system, and received from Healthgrades the 2017 America’s 100 Best Hospitals Award™, 2017 Patient Safety Excellence Award™ and the 2017 Outstanding Patient Experience Award™—a unique trio of awards that only three hospitals in the nation were able to achieve. Heart Hospital of Austin has been named one of the Top 50 Cardiovascular Hospitals in the nation by Truven Health Analytics for ten years and to Truven's list of 100 Top Hospitals for five years, in conjunction with St. David’s Medical Center.
Cardiothoracic and Vascular Surgeons, PA
For almost six decades, Cardiothoracic and Vascular Surgeons (CTVS) has been proud to offer Central Texas the most specialized and innovative cardiothoracic and vascular surgical care available. The most sophisticated diagnostic and surgical techniques are provided by more than 20 CTVS surgeons from offices in Central Austin, Williamson County, Hays County, and all area hospitals. Individually and collectively, CTVS surgeons have amassed a record of medical “firsts” in Central Texas, including performing the first heart and kidney transplants in the area. Since 1958, the surgeons along with the clinical team of physician assistants, nurses, and technicians, have shared a commitment to patients, their health and the community. To learn more about Cardiothoracic and Vascular Surgeons, please call (512) 459-8753 or visit us online at CTVSTexas.com.