The US Food and Drug Administration (FDA) approved the investigational device exemption (IDE) trial for the GORE TAG thoracic branch endoprosthesis in the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery (LSA).
The GORE TAG thoracic branch endoprosthesis builds on more than 15 years of Gore experience in aortic innovation. Designed for long-term durability, the device allows for femoral-only access over a pre-positioned branch guidewire for ease of implantation.
The device also features the CARMEDA bioactive surface (CBAS heparin surface) for sustained anti-thrombotic bioactivity, as is present on many of Gore’s peripheral vascular products.
Gore Aortic business unit leader Ryan Takeuchi noted the company is committed to designing innovative solutions that treat challenging patient populations.
"Long-term durability and patient outcomes are the cornerstone of our research and development," said. We dedicated significant time and effort into the development of our thoracic branch technology and it has become the foundation of our aortic branch portfolio.
"Earlier this year, we introduced our first branched device with the GORE EXCLUDER Iliac Branch Endoprosthesis with much clinical success across Europe. Now with our GORE TAG Thoracic Branch Endoprosthesis, physicians will be able to treat a subset of patients that could not be considered for total endovascular repair in the past," Takeuchi added.
Gore accomplished several key regulatory milestones in 2013. The GORE excluder iliac branch endoprosthesis received CE Mark in October 2013 and is currently available for investigational purposes only in the US.
Additionally, the FDA approved the Conformable GORE TAG thoracic endoprosthesis for the treatment of acute and chronic dissections, making it the first and only stent-graft that is FDA approved to treat aneurysms, traumatic transections, and dissections of the thoracic aorta.
