FDA Approves More Accurate GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Gore just announced winning FDA approval for its GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The thoracic endovascular aortic repair system is based on the Conformable GORE TAG Device, but with a new, more robust control mechanism that helps to position the implant with greater accuracy and confidence.

The implant itself is the same highly conformable endovascular prosthesis that has proven itself at treating aneurysms, transections, and Type B dissections of the descending thoracic aorta. It is the delivery mechanism for the implant that allows physicians to take full advantage of the prosthesis, allowing them more flexibility in the positioning and angulation. This is thanks to a two-stage deployment procedure that first expands the implant to an intermediate diameter and only later to full diameter, which allows blood to flow through while the prosthesis is placed.

Some more details according to Gore:

No change was made to the 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.

Product page: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL…

Via: Gore…