Gore today announced the first ever implantation of the Gore Tag thoracic branch endoprosthesis (TBE) in Europe. The patient was treated by Dittmar Böckler, chief of the Department of Vascular Surgery and Endovascular Surgery at University Hospital Heidelberg in Germany.
The device is indicated for endovascular repair of lesions in the descending thoracic aorta of patients with the appropriate anatomy, including isolated lesions, such as aneurysms, traumatic transections and type B dissections, while maintaining flow into the left subclavian artery.
Rigorous in vitro and in vivo testing and extensive clinical trials have demonstrated the safety and performance of the device, which has become the first endovascular graft for the aortic arch to be granted both US Food and Drug Administration (FDA) and Medical Device Regulation (MDR) CE mark approval.
The pivotal study conducted in the USA enrolled 238 patients requiring treatment across multiple aortic pathologies, including the left subclavian artery (LSA). All patients were enrolled with a technical success rate of 95.8%, reintervention rate of 2.9%, LSA branch patency of 99.2% and disabling stroke rate of 3.4% through 12 months of follow-up.
“Treating aortic arch disease has traditionally posed challenges. Current options involve procedures like open surgery, hybrid approaches with surgical revascularisation, or those that use non-CE mark devices. As a complete, single-device system, the Gore Tag thoracic branch endoprosthesis simplifies the treatment of zone 2 revascularisation by eliminating the need for surgical LSA debranching. The ability to endovascularly perfuse the left subclavian artery plays a key role in minimising surgical procedures and related risks. We are excited about this next significant step in treating a broader range of patients with this innovative device,” Böckler commented.
A press release details that the Gore Tag TBE, designed for long-term durability, is the first off-the-shelf aortic branched zone 2 device to be approved in Europe under the new MDR CE mark regulation. “The Gore Tag Thoracic Branch Endoprosthesis combines the proven conformability and durability of the GORE TAG Conformable Device with the ability to endovascularly perfuse the left subclavian artery,” said Eric Zacharias, medical products division leader at Gore. “This approval is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market.”
