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May 15, 2019

FDA Approves Gore's TAG Conformable Thoracic Stent Graft With Active Control

May 15, 2019—Gore & Associates announced that the FDA has approved the company's TAG conformable thoracic stent graft with Active Control system for thoracic endovascular aortic repair. The device and delivery system provide 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.

According to Gore, the 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.

Gore advised that no change was made to the stent graft itself, which 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 6% to 33% oversizing window allows physicians to choose the optimal radial force to fit patient anatomy and etiology. The 16- to 42-mm range can be treated with as few as five sizes, allowing providers to stock fewer devices while treating a broader range of patients, stated the company.

The TAG conformable thoracic stent graft with Active Control system was approved for use in Europe in July 2017 and in Australia in July 2018.

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