Gore Receives FDA Approval for Conformable Gore Tag Stent Graft
November 18, 2011 – W. L. Gore & Associates Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the Conformable Gore Tag thoracic endoprosthesis as a minimally invasive treatment for patients suffering from thoracic aortic aneurysms (TAAs). The announcement came at the VEITH Symposium 2011 Conference in New York. The device is the only FDA-approved polytetrafluoroethylene (PTFE) thoracic endoprosthesis designed for endovascular repair of the descending thoracic aorta that offers conformability and ease of use, while accommodating tapered anatomy and resisting compression. The broad oversizing window for the device ranges from six to 33 percent, allowing physicians to choose the appropriate oversizing for the patient anatomy.
William Jordan, M.D., chief of vascular surgery at the University of Alabama, Birmingham, served as national principal investigator for the Conformable Gore Tag Device in the Thoracic Aortic Aneurysm Trial (Gore TAG 08-03) over the past two years. According to Jordan, “This new device represents a substantial product improvement brought to us by a company that was already leading the market in aneurysm devices. Gore evaluated the real-world results of the first generation endograft and engineered improvements so that the device can be used across a wider range of aortic diameters with stronger radial force to resist compression. These modifications are intended to improve the lives of our patients and provide better outcomes for challenging clinical problems.”
The following physicians completed successful procedures using the Conformable Gore Tag thoracic endoprosthesis during the first week of release:
* William McMillan, M.D. – vascular surgeon at Minneapolis Vascular Physicians
* Robert Mitchell, M.D. – thoracic surgeon at Central Baptist Hospital, Lexington, Ky.
* Brian Peterson, MD – vascular surgeon in the Department of Surgery at Saint Louis University
* Robert Rhee, MD - associate professor of surgery at the University of Pittsburgh Medical Center
* Joshua Rovin, MD - cardiovascular surgeon at Bayfront Medical Center, St. Petersburg, Fla.
* Daniel Watson, MD – director of endovascular surgery at Riverside Methodist Hospital, Columbus, Ohio
The device is available in diameters of 21-45 mm, allowing for the treatment of patients with aortic diameters of 16-42 mm. Tapered device configurations are also available.
TAAs are a serious health risk because they can burst or rupture with little or no symptoms after developing over years. 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 of the abdominal aorta. Due to the high mortality risk associated with undetected and untreated TAAs, it is critical to get screened for aneurysm risk and seek early treatment if detected.
“The Gore Tag device has been a leading endovascular treatment option for safely and effectively treating patients with aneurysms of the descending thoracic aorta. The device is backed by a proven safety record with more than 50,000 devices distributed worldwide and a decade of worldwide clinical data,” said David Abeyta, Gore aortic business leader. “Now featuring design enhancements such as a modified stent frame, optimized graft film layers, enhanced conformability and expanded oversizing ranges, the Conformable Gore Tag device provides an optimal fit and maximum conformability for each patient’s anatomy without compromising conformability.”
For more information: www.goremedical.com