Gore announced at the VEITHsymposium that it has received regulatory clearance from Health Canada’s Therapeutic Products Directorate to market the Gore Excluder AAA Endoprosthesis and Gore TAG Thoracic Endoprosthesis in Canada. Planning is underway for Canadian physician training on the devices, and the subsequent commercial product release timeline will be announced in the near future. The two Gore devices were previously granted regulatory approval in the US, Europe, Japan and South Korea.
The Excluder AAA Endoprosthesis is an endovascular graft and stent combination that seals off the aneurysm and creates a new path for the blood to flow. The TAG Thoracic Endoprosthesis internally relines the thoracic aorta and isolates the diseased segment from blood circulation. It is comprised of an ePTFE graft with an outer self-expanding nitinol support.