Today Gore announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for commercial distribution for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, a unique Thoracic Endovascular Aortic Repair (TEVAR) solution combining new levels of control with the proven legacy and trusted performance of the Conformable GORE® TAG® Device. The device and delivery system provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B dissections of the descending thoracic aorta. A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes.
The GORE® ACTIVE CONTROL System provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter. This design allows for continuous blood flow throughout the deployment with multiple opportunities to visualize and refine graft placement. It is also designed to allow for angulation of the proximal end of the device for improved seal and apposition. It gives physicians added precision in placement and angulation so they can take full advantage of the exceptional conformability of the Gore device and confidently provide a minimally-invasive solution to more patients.
No change was made to the GORE® TAG® Conformable Thoracic Stent Graft itself, which, as the world’s most-studied* TEVAR device, has demonstrated long-term freedom from device-related reintervention (93.1%) and low complication rates (zero migrations, fractures, or compressions).** Large device oversizing windows were engineered, tested, and proven to accommodate differences in proximal and distal landing zone diameters; a unique 6% to 33% oversizing window allows physicians to choose the optimal radial force to fit patient anatomy and etiology, whether treating a young trauma patient or a fragile dissected aorta. The 16mm to 42mm range can be treated with as few as five sizes, allowing providers to stock fewer devices while treating a broader range of patients.
“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,” said Eric Zacharias, a vascular business leader at Gore. “Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with challenging 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.”
The GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support team and educational offerings. The portfolio of products includes the GORE® EXCLUDER® AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA). The GORE® EXCLUDER® Iliac Branch Endoprosthesis is the first FDA-approved, off-the-shelf device for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, and is intended for use with the GORE EXCLUDER AAA Endoprosthesis.†
* Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.
** Consolidated site reported outcomes following 5 years of follow-up in TAG 08-01, TAG 08-02, TAG 08-03 clinical studies.