Gore has announced the first patient enrolment in its post-market European registry for the Gore TAG Conformable Thoracic Stent Graft with Active Control System, following its recent European launch in July 2017. The thoracic endovascular aortic repair (TEVAR) device is the first to feature a new delivery system that provides the physician with controlled, staged deployment.
The first patient procedure in the registry was performed by Giovanni Torsello and Martin Austermann at St Franziskus Hospital, Münster, Germany. Torsello, chief of the Department of Vascular Surgery, stated, “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.”
The registry, known as SURPASS, will enrol 125 patients who will be followed for 12 months at up to 20 sites across Europe. Data from the registry will evaluate the real-world efficacy of the Gore TAG Conformable Thoracic Stent Graft with Active Control System in the treatment of aetiologies of the descending thoracic aorta, including aneurysms, transections, and all type B dissections. Torsello will serve as the global principal investigator for the registry.
The Gore Active Control System enhances the exceptional conformability of the stent graft, facilitating the optimised wall apposition that the Conformable Gore TAG Device is renowned for even in complex anatomies, such as acute aortic angles. The novel, staged deployment feature enables the physician to refine positioning of the stent graft within the body to achieve optimal placement prior to full-diameter expansion. The angulation control capability allows the physician 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 challenging anatomies.
The new product offering features the same time-tested stent graft as the Conformable Gore TAG device that has demonstrated long-term freedom from device-related reintervention (93.1%) and low complication rates (zero migrations, fractures, or compressions). The device is a unique combination of proprietary ePTFE graft material and a fully supported, nested nitinol stent.
“The Conformable GORE TAG Device is already the most-studied thoracic endograft available on the market,” said Eric Zacharias, vascular business leader at Gore. “We continue to evolve the product to better meet the needs of patients and the physicians who treat them. High-quality, real-world clinical data will continue to be crucial for us to maintain the trusted quality, safety, and effectiveness of this device.”