W.L. Gore & Associates said today that it won a nod from the FDA for its Gore Tag conformable thoracic endovascular aortic repair stent graft with Active Control.
The newly cleared Gore Tag TEVAR product features the Flagstaff, Ariz.-based company’s Active Control system, which it said provides a controlled, two-stage deployment. The initial deployment is to an intermediate diameter, while the secondary deployment is to the full diameter, the company said.
Gore said that the multi-stage deployment allows for continuous blood flow with multiple opportunities to visualize and refine the graft placement, as well as angulation of the proximal end for improved seal and apposition.
The stent graft itself is similar to previous generation products, with Gore touting it as the “world’s most-studied TEVAR device.”
“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 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,” vascular biz leader Eric Zacharias said in a press release.
In January, Gore released 12-month results from a registry study of its Gore Tigris vascular stent designed to treat peripheral artery disease in the superficial femoral artery and proximal popliteal artery, touting that the device was shown to be safe and effective.