Gore has announced the first US implant of its Gore TAG conformable thoracic stent graft with ACTIVE CONTROL system. The successful procedure was performed by William Jordan, chief of the Division of Vascular Surgery and Bradley Leshnower, cardiothoracic surgeon, at the Emory University School of Medicine in Atlanta, USA. This first case follows the recent US Food and Drug Administration approval for this new device.
The system delivers new levels of control in the endovascular repair of aneurysms, transections, and Type B dissections of the thoracic aorta. A key feature of this device is a delivery system which provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter. In addition to the staged deployment, a lockwire keeps the stent graft attached to the catheter through the procedure, enhancing the physician’s control. The device also features a full 2F reduction in profile over previous designs across 10 device sizes.
“The two-stage deployment provided by the Gore TAG conformable thoracic stent graft with ACTIVE CONTROL system allows for continuous blood flow, and it gives me multiple opportunities to visualise and refine graft placement for accurate placement and peace of mind,” said Jordan. “The new delivery system gives me added precision in placement and angulation so I can take full advantage of the conformability of the Gore device and confidently provide a minimally-invasive solution to more patients, even in patients with complex anatomy.”
The system received CE Mark in 2017. At 30-day follow-up, the device demonstrated 100% successful deployment and zero type IA or type III endoleaks, fractures, device compressions or ruptures, according to real-world data from the post-market European observational, single-arm SURPASS registry. No device-related issues were reported by 98.4% of registry participants, and 97.2% of registry subjects were reported free from serious access complications. Further, 98.4% of registry participants reported improved proximal wall apposition at procedural completion, and 92.9% reported no rapid pacing was used.
“Gore has continuously partnered with physicians to innovate and evolve our stent graft offerings to deliver better long-term patient care,” said Eric Zacharias, vascular business leader at Gore. “We engineered this device with the goal of overcoming known thoracic endovascular aortic repair (TEVAR) limitations related to control and accuracy during deployment. With this new milestone, Gore continues its commitment to developing solutions that advance the treatment of endovascular aortic disease.”