Gore has announced the first patient implant of the TAG conformable thoracic stent graft with Active Control system after the receipt of CE mark last month. The first implant was performed by Giovanni Torsello and Martin Austermann at St Franziskus Hospital, Munster, Germany.
The thoracic endovascular aneurysm repair (TEVAR) device is the first to feature a new delivery system that provides the physician with controlled, staged deployment. The system optimises accuracy, angulation, and apposition to treat aetiologies of the descending thoracic aorta including aneurysms, transections, and acute and chronic type B dissections. The new device will be formally launched in European regions later this year.
Gore says that the Active Control system enhances the conformability of the stent graft; facilitating the optimised wall apposition of the conformable TAG device even in complex anatomies, such as acute aortic angles. The novel staged deployment feature enables the physician to refine positioning and angulate the stent graft within the body to achieve optimal placement prior to full-diameter expansion. The angulation control capability gives physicians the option to angulate the device to achieve orthogonal placement to the aortic blood flow lumen and maximise conformability and seal. These features enable physicians to more confidently perform endovascular treatment even in anatomies where tortuous vessels might historically have suggested open surgery.
“The enhanced control capabilities this new delivery system allows could reduce many common complications that can occur if the stent graft is not placed correctly during the TEVAR procedure,” commented Torsello. “Secondary interventions can be traumatic for patients and costly to the provider. The innovative staged deployment feature of the Active Control system provides a level of precision that has never existed in TEVAR. This level of control in combination with the long-term benefits of the stent graft is a significant advancement for the field.”
The new product offering features the same time-tested stent graft as the conformable TAG device, whose predictable outcomes have been established through its long-term freedom from reintervention (89%) and low serious endoleak (6%) and migration (0%) rates through five years. The device is a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent.
“Since Gore pioneered the first TEVAR device in Europe two decades ago, we have welcomed feedback from our physician partners to innovate and evolve our stent graft offerings for better long-term patient care,” said Eric Zacharias, vascular business leader at Gore. “The TAG device family has a legacy of trusted performance and durability, and we knew we could build on that by enhancing control during deployment which would help make TEVAR procedures more predictable for physicians. Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with extremely angulated aortic arches, and meet the clinical and practical challenges of TEVAR with confidence.”