Technology | November 18, 2011

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:

Related Content

FDA Grants Breakthrough Device Designation for Valiant Thoracoabdominal Aortic Aneurysm Stent Graft
News | Stent Grafts | October 09, 2019
Medtronic plc announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA...
PQ Bypass Granted IDE Approval to Start TORUS SFA Stent Graft Pivotal Study
News | Stent Grafts | October 08, 2019
PQ Bypass Inc. announced it has received full approval of its investigational device exemption (IDE) trial of the...
First U.S. Patient Receives Gore Tag Conformable Thoracic Stent Graft With Active Control
News | Stent Grafts | July 10, 2019
W. L. Gore & Associates Inc. (Gore) announced the first U.S. implant of the Gore Tag Conformable Thoracic Stent...
Gore Receives FDA Approval for Gore Tag Conformable Thoracic Stent Graft
Technology | Stent Grafts | May 15, 2019
W. L. Gore & Associates Inc. (Gore) announced the U.S. Food and Drug Administration (FDA) has granted regulatory...
Aortic Stent Graft Global Market to Reach $5.4 Billion by 2028
News | Stent Grafts | February 14, 2019
Abdominal aortic stent grafts will remain the largest segment in the global aortic stent graft market at least through...
Medtronic Receives FDA Approval for Valiant Navion Thoracic Stent Graft System
Technology | Stent Grafts | February 07, 2019
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion thoracic stent...
Endologix Ends Unrestricted Sales and Use of Nellix System
News | Stent Grafts | January 07, 2019
January 7, 2019 — Endologix Inc.
Endologix Reports Positive One-Year Results From the Ovation LUCY Study
News | Stent Grafts | July 16, 2018
Endologix Inc. announced one-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for...
FDA Committee Votes in Favor of Incraft AAA Stent Graft System
News | Stent Grafts | June 13, 2018
Cardinal Health announced that its Incraft Abdominal Aortic Aneurysm (AAA) Stent Graft System has received a favorable...
First Patient Enrolled in Gore Excluder Investigational Study
News | Stent Grafts | January 08, 2018
January 8, 2018 — W. L. Gore & Associates Inc.