First European Patient Treated Using Gore Medical's GORE TAG Thoracic Branch Endoprosthesis

This week, Gore Medical, a global materials science company that engineers medical devices, announced the first-ever implantation of the GORE TAG Thoracic Branch Endoprosthesis in a patient in Europe.

A first-of-its-kind device, the GORE TAG Thoracic Branch Endoprosthesis is designed to simplify minimally invasive zone 2 thoracic endovascular aortic repair procedures. It is indicated for the endovascular repair of lesions in the descending thoracic aorta, including isolated lesions, such as aneurysms, traumatic transections, and type B dissections, while it maintains flow into the left subclavian artery.

The GORE TAG Thoracic Branch Endoprosthesis has undergone rigorous in vitro and in vivo testing and extensive clinical trials. A pivotal study conducted in the United States comprising 238 patients requiring treatment across multiple aortic pathologies, including the left subclavian artery (LSA) yielded a technical success rate of 95.8%, a reintervention rate of 2.9%, an LSA branch patency of 99.2%, and a disabling stroke rate of 3.4% through 12 months of follow-up.

Because of its demonstrated safety and efficacy, the GORE TAG Thoracic Branch Endoprosthesis has become the first endovascular graft for the aortic arch to be granted approval from the US Food and Drug Administration and receive a Medical Devices Regulation CE marking certification.

“Treating aortic arch disease has traditionally posed challenges. Current options involve procedures like open surgery, hybrid approaches with surgical revascularization, or those that use non-CE marked devices,” said Prof. Dittmar Böckler, chief of the Department of Vascular Surgery and Endovascular Surgery at University Hospital in Heidelberg, Germany, who treated the first European patient to be implanted with the GORE TAG Thoracic Branch Endoprosthesis.

“The ability to endovascularly perfuse the left subclavian artery plays a key role in minimizing surgical procedures and related risks,” he said. “We are excited about this next significant step in treating a broader range of patients with this innovative device.”