W. L. Gore & Associates has announced first commercial in-human use of TAG conformable thoracic stent graft with Active Control system for TEVAR in Australia.
The thoracic endovascular aortic repair (TEVAR) device is claimed the first to house a new delivery system that offers a physician with controlled, staged deployment.
The first implants were undertaken by Professor Ian Spark at Flinders Medical Centre, Adelaide, South Australia.
The system is claimed to optimize accuracy, angulation and apposition for the treatment of etiologies of the descending thoracic aorta including aneurysms, transections, and acute and chronic Type B dissections.
The Gore Active Control system improves the conformability of the stent graft, supporting optimized wall apposition that the Conformable GORE TAG Device is known for in complex anatomies including acute aortic angles.
This staged deployment feature allows physicians to refine positioning and angulate the stent graft within the body to achieve an optimal placement prior to full-diameter expansion.
The angulation control capability gives physicians the option to angulate the device to achieve orthogonal placement to the aortic blood flow lumen and maximize conformability and seal.
These features let physicians to confidently perform endovascular treatment even in anatomies where tortuous vessels may historically have suggested open surgery.
The TAG Conformable Thoracic Stent Graft features the same stent graft as the Conformable GORE TAG Device, whose outcomes were established through long-term freedom from reintevention (89 percent for aneurysms in the descending thoracic aorta and 100 percent for traumatic transections), through five years and 90% dissection-related survival through 1 year. The device combines ePTFE graft material and a fully supported, nested, nitinol stent.
Gore vascular business leader Eric Zacharias said: “Since Gore pioneered the first TEVAR device in Europe two decades ago, we have welcomed feedback from our physician partners to innovate and evolve our stent graft offerings for better long-term patient care.
“The GORE TAG Device family has a legacy of trusted performance and durability, and we knew we could build on that by enhancing control during deployment which would help make TEVAR procedures more predictable for physicians.
“Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with extremely angulated aortic arches, and meet the clinical and practical challenges of TEVAR with confidence. With this latest product iteration, Gore is continuing its unparalleled commitment to developing solutions that advance endovascular solutions for diseases of the aorta.”