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November 6, 2009
Conformable Gore TAG Thoracic Endoprosthesis Approved in Europe
November 7, 2009—W.L. Gore & Associates (Flagstaff, AZ) announced that it has received European CE Mark approval for the next-generation Gore TAG thoracic endoprosthesis. The Conformable Gore TAG is available in Europe in an expanded portfolio of sizes. It is designed to treat multiple etiologies including thoracic aortic aneurysms, traumatic aortic transections, and thoracic aortic dissections. The device is engineered for flexibility and conformability for performance in tortuous anatomy.
According to the company, design enhancements to the next-generation Conformable Gore TAG thoracic endoprosthesis include a modified stent frame, repositioned gold bands, and optimized graft film layers for improved conformability in tortuous anatomies. The device will be available in diameters of 21 to 45 mm, allowing for the treatment of patients with aortic diameters of 16 to 42 mm. Tapered device configurations will also be available. The Conformable Gore TAG also offers a modified device delivery catheter that is designed for enhanced trackability and deliverability to the target. The sheathless delivery catheter provides flexibility for navigating tortuous anatomy and low deployment forces.
Dittmar Bšckler, MD, and Thomas Larzon, MD, were the first European interventionists to implant the company's next-generation device. Professor Bšckler commented, "The Conformable Gore TAG device achieved excellent wall apposition and conformed to the thoracic aorta, thus allowing us to treat more patients with individual anatomies."
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