Gore receives FDA approval for Conformable Gore Tag thoracic endoprosthesis

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The US Food and Drug Administration FDA has approved the Conformable Gore Tag thoracic endoprosthesis (Gore) as a minimally invasive treatment for patients suffering from thoracic aortic aneurysms (TAAs). 

According to Gore & Associates, the device is the only FDA approved ePTFE 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 6-33%, allowing physicians to choose the appropriate oversizing for the patient anatomy.


“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,” said William Jordan, chief of Vascular Surgery at the University of Alabama, Birmingham, USA, and national principal investigator for the Conformable Gore Tag device in the Thoracic Aortic Aneurysm Trial over the past two years.


The following physicians completed successful procedures using the Conformable Gore Tag thoracic endoprosthesis during the first week of release:

  • William McMillan, vascular surgeon at Minneapolis Vascular Physicians
  • Robert Mitchell, thoracic surgeon at Central Baptist Hospital, Lexington, Kentucky
  • Brian Peterson, vascular surgeon in the Department of Surgery at Saint Louis University
  • Robert Rhee, associate professor of Surgery at the University of Pittsburgh Medical Center
  • Joshua Rovin, cardiovascular surgeon at Bayfront Medical Center, St. Petersburg, Florida
  • Daniel Watson, 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.

 

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