Gore Launches TAG Conformable Thoracic Devices With Reduced Profiles in Europe
January 21, 2019—Gore & Associates announced the commercial introduction in Europe of reduced profiles for the most commonly used diameters of its TAG conformable thoracic stent graft with Active Control system. The reduced profile allows physicians to perform thoracic endovascular aneurysm repair (TEVAR) in patients with smaller vessels where access is challenging and aortic anatomy is tortuous. The reduced profiles of critical sizes allow the device to be introduced through a smaller sheath.
According to the company, the TAG conformable thoracic stent graft was modified to reduce the delivery profile of the 31-, 37-, and 40-mm device diameters by 2 F for all lengths. The reduction in profile, through the use of a smaller diameter primary sleeve, is the only change to the device.
The conformable TAG device has established long-term freedom from reintervention rate of 93.1% and low complication rates, with zero migrations, fractures, or compressions. The access site complication rate is 2.4%. The device combines Gore's expanded polytetrafluoroethylene graft material and a fully supported, nested nitinol stent. The Active Control system facilitates optimized wall apposition.
In Gore's announcement, Professor Dittmar Boeckler, MD, commented, “As the market for TEVAR has continued to expand and evolve, lower-profile devices have rapidly emerged with a goal of increased patient applicability, accessibility, trackability, and finally reducing access complications for patients with smaller vessels. It’s reassuring that the new reduced profile sizes of the Gore TAG conformable thoracic stent graft was achieved without changes to the stent graft."
Prof. Boeckler continued, "Gore’s device is known for its conformability, and the Gore Active Control system enables me to take full advantage of the conformability by allowing precise placement during TEVAR procedures. The combination of controlled delivery with the trusted stent graft, and now reduced profile for the device, is a significant advancement and approaches unmet needs performing TEVAR in my daily practice."