W. L. Gore & Associates (Gore) today announced the first human implants of the next generation Conformable GORE TAG® Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The first implants were performed by Joshua Rovin, MD and Eugene Murphy, MD, at Bayfront Medical Center and William McMillan, MD and Scott Schultz, MD, at North Memorial Medical Center. The devices were used to treat patients with a TAA, which is an enlargement that develops in weakened areas in the thoracic aorta. Dr. Joshua Rovin, cardiovascular surgeon at Bayfront Medical Center said, “It is exciting to be part of the clinical trial for the next generation Conformable GORE TAG® Device.”
Gore received approval of an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to investigate the use of the next generation Conformable GORE TAG® Thoracic Endoprosthesis in thoracic aortic aneurysms. William Jordan, MD, from the University of Alabama, Birmingham, will serve as the national principle investigator (PI) in the Conformable GORE TAG® Device in Thoracic Aortic Aneurysm Trial (Gore TAG 08-03). “This study will evaluate device performance across the wide portfolio of sizes available with the next generation Conformable GORE TAG® Device,” stated Dr. Jordan. The next generation Conformable GORE TAG® Device portfolio includes device diameters ranging from 21 – 45 mm as well as tapered devices, and the study will investigate the treatment of patients with aortic diameters of 16 – 42 mm.
The commercially available GORE TAG® Thoracic Endoprosthesis provides a minimally invasive option for safely and effectively treating patients with aneurysms of the descending thoracic aorta (DTA). It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. It received pre-market approval from the FDA in 2005.
In addition to TAAs, the next generation Conformable GORE TAG® Device has been approved to investigate endovascular repair of other etiologies including traumatic aortic transection and aortic dissection. Design enhancements include a modified stent frame, repositioned gold bands, and optimized graft material.
A TAA occurs slowly, over several years, with little or no symptoms. TAAs are a serious health risk because they can burst or rupture. A ruptured aneurysm can cause severe internal bleeding, which can rapidly lead to shock or death. Thoracic aneurysms affect approximately 15,000 people in the United States each year. Some patients may have more than one TAA or may also have an aneurysm in the abdominal aorta. Only about 20 to 30 percent of patients who get to the hospital with a ruptured TAA survive. For this reason, it is crucial to treat aneurysms early in order to prevent their rupture.
“The GORE TAG® Device has remained the leading option for less invasive treatment of TAA with a proven safety record supported by more than ten years of worldwide clinical data,” said David Abeyta, Aortic Business Unit Leader at Gore. “The various clinical trials we are initiating for the Conformable GORE TAG® Device represent part of Gore’s ongoing commitment to provide clinicians with life-saving, minimally invasive solutions.”