The US Food and Drug Administration (FDA) has approved W. L. Gore & Associates’s (Gore) Conformable Gore TAG thoracic endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta.
The thoracic endoprosthesis, which is designed for multiple thoracic etiologies, is reportedly the only device to receive the FDA indications for aneurysm, trauma and dissection.
Conformable Gore TAG thoracic endoprosthesis is available in 21-45mm diameters. It resists compression and has a broad oversizing window ranging from 6-33%.
The new device accommodates tortuous and tapered anatomy, and allows the treatment of patients with aortic diameters of 16-42mm.
Gore aortic business leader Ryan Takeuchi noted this approval further advances the use of endovascular devices as standard of care and allows more patients to benefit from this preferred treatment option.
"Gore has always been on the cutting edge of endovascular treatment and was the first to gain approval for thoracic aortic aneurysm followed by aortic traumas using our Conformable GORE TAG Device," Takeuchi added.