July 9, 2019
Gore's TAG Conformable Thoracic Stent Graft With Active Control System Launched in the United States
July 10, 2019—Gore & Associates announced the commercial launch in the United States of the company's TAG conformable thoracic stent graft with Active Control system, with the first implantation of the device performed by William Jordan, MD, from Emory University School of Medicine in Atlanta, Georgia.
In May, the company announced FDA approval of the TAG conformable device and delivery system for thoracic endovascular aortic repair of aneurysms, transections, and type B dissections of the thoracic aorta. European CE Mark approval was received in 2017.
According to the company, the device's delivery system provides a 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 lock wire keeps the stent graft attached to the catheter throughout the procedure, enhancing the physician’s control. The device also features a full 2-F reduction in profile over previous designs across 10 device sizes.
Dr. Jordan commented in Gore's announcement, “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 visualize and refine graft placement for accurate placement and peace of mind. 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 company noted that 30-day follow-up data from the European real-world, postmarket, observational, single-arm SURPASS registry of the device demonstrated 100% successful deployment and zero type Ia or type III endoleaks, fractures, device compressions, or ruptures. Additionally, no device-related issues occurred in 98.4% of registry participants, and 97.2% of registry subjects were reported to be free from serious access complications. Further, 98.4% of registry participants had improved proximal wall apposition at procedural completion, and 92.9% did not use rapid pacing.