Gore Scores FDA Nod for More Precise TEVAR Solution

W.L. Gore and Associates has received a nod from FDA for a more precise Thoracic Endovascular Aortic Repair (TEVAR) solution. The Flagstaff, AZ-based company said the Gore Tag Conformable Thoracic Stent Graft with Active Control System provides 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. “Gore has been on the front end and has really defined and established the TEVAR minimally invasive repair of the thoracic aorta going back more than 10 years now,” Eric Zacharias, a vascular business leader at Gore, told MD+DI. “Over that time, we’ve [been able to] broaden the treatment of a range of disease states that need repair of the thoracic aorta.” Zacharias added, “More recently, the change we made was going after the improvement of the delivery system. The [Gore Tag Conformable Thoracic Stent Graft] is known as a device that treats a wide range of anatomies and fits the anatomy really naturally.” 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 wit...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news