W.L. Gore Tag Thoracic Stent Graft Approved

FDA has approved a W. L. Gore PMA for the Gore Tag Conformable Thoracic Stent Graft with Active Control System, an endovascular aortic repair device. The device and delivery system is designed to provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B dissections of the descending thoracic aorta, the company says. “A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes,” it says.

The device provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter, Gore says. “This design allows for continuous blood flow throughout the deployment with multiple opportunities to visualize and refine graft placement,” it says. “It is also designed to allow for angulation of the proximal end of the device for improved seal and apposition.”