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FDA Grants Clearance To Market A Modified Version Of GORE TAG Thoracic Endoprosthesis

W. L. Gore & Associates (Gore) announced that it has received approval from the US FDA to market a modified version of the GORE TAG Thoracic Endoprosthesis at the annual International Congress of Endovascular Interventions XXII. The approval for the catheter system is for the treatment of thoracic aortic aneurysms (TAAs). The enhancement to the previous version of the catheter system is a soft flexible tip to the leading end of the delivery system that enables the improved delivery. The soft tip improves flexibility at the wire / catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been modified to improve ease of use and durability. GORE TAG Thoracic Endoprosthesis internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The catheter system is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient’s groin.