Gore’s TAG Conformable Thoracic Stent Graft With Active Control System Approved in Europe
July 13, 2017—Gore & Associates announced the first patient implant of its TAG conformable thoracic stent graft with Active Control System, which received European CE Mark approval in June for thoracic endovascular aortic repair (TEVAR). Professor Giovanni Torsello, MD, and Martin Austermann, MD, performed the procedure at St. Franziskus Hospital in Münster, Germany. The device will formally be launched in European regions later this year.
The TAG conformable device is composed of the company's expanded polytetrafluoroethylene graft material and a fully supported, nested nitinol stent. The new delivery system provides the physician with controlled, staged deployment by optimizing accuracy, angulation, and apposition to treat etiologies of the descending thoracic aorta including aneurysms, transections, and acute and chronic type B dissections.
The Active Control System enhances the conformability of the stent graft, facilitating the device's optimized wall apposition even in complex anatomies, such as acute aortic angles.
According to Gore, the device's staged deployment feature enables the interventionalist to refine positioning and angulate the stent graft within the body to achieve optimal placement before 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 maximize conformability and seal.
In the company's announcement, Prof. Torsello commented, “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. Secondary interventions can be traumatic for patients and costly to the provider. The innovative staged deployment feature of the Gore 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.”