European Postmarket Registry Begins for Gore's TAG Conformable Thoracic Stent Graft With Active Control System
November 2, 2017—Gore & Associates recently announced the first enrollment in its postmarket European SURPASS registry for its TAG conformable thoracic stent graft with Active Control system. In July, the company announced the launch of the device, which received European CE Mark approval in June for thoracic endovascular aortic repair (TEVAR). The device's new delivery system is designed to allow controlled, staged deployment.
According to the company, the SURPASS registry will enroll 125 patients who will be followed for 12 months at up to 20 sites in Europe. Data from the registry will evaluate the real-world efficacy of the TAG conformable thoracic stent graft with Active Control system in the treatment of etiologies of the descending thoracic aorta, including aneurysms, transections, and all type B dissections. Professor Giovanni Torsello, MD, will serve as the Global Principal Investigator for the registry. Prof. Torsello performed the first patient procedure in the registry with Martin Austermann, MD, at St. Franziskus Hospital in Münster, Germany.
In Gore's announcement, Prof. Torsello commented, "The Gore Active Control system was easy to use and provided a noticeably enhanced level of control in the placement and angulation of the Gore TAG conformable thoracic stent graft. Enrolling patients in Gore’s registry will help to determine the short- and long-term benefits of this new device, which we expect could include the reduction of complications that can occur if the stent graft is not placed correctly during the TEVAR procedure. The precise control of this stent graft is an exciting advancement for TEVAR, and we are happy to be of the first physicians to experience it.”