A D V A N C E D M A T E R I A L S & P R O C E S S E S | A P R I L 2 0 2 2 5 5 TECHNICAL SPOTLIGHT deploys the stent graft to its intermediate diameter, initiating device opening from the leading to the trailing ends (Fig. 2). At this intermediate stage, the angulation control dial is now accessible and the user has the first opportunity for optional angulation of the proximal end of the stent graft by rotating this dial. Removal of the secondary deployment handle deploys the stent graft to its full diameter, initiating deployment from the trailing to leading ends. The angulation control dial remains accessible even after full expansion, and the user has a second opportunity for optional angulation at full diameter. Throughout the deployment, the stent graft is secured onto the catheter via a lock wire. This ensures control of device positioning throughout the procedure until removal of the lock wire handle. Finally, the angulation assembly handle is removed to withdraw the angulation fiber mechanism. The GORE® DEVICE has two important features to improve deployment predictability through accuracy and control: staged deployment and in situ angulation control of the proximal end of the stent graft. With staged deployment, the nested handle delivery systemdesign enables the stent graft to deploy in two distinct steps (Fig. 3). Removal and actuation of the first primary deployment handle opens the device along its entire length to its intermediate diameter, which is approximately 50% of its nominal diameter. Importantly, this deployment to intermediate diameter is designed to allow continuous blood flow both through the lumen of the stent graft and around the device. This feature ensures hemodynamic stability throughout the procedure, even in the aortic arch with its characteristic high blood flow pressure and velocity. A unique advantage of this design is that blood pressure does not have to be aggressively reduced because the blood flow into the distal aorta is not compromised. The lack of windsocking forces that tend to push the device distally during device opening helps to ensure precise positioning of the stent graft in the aorta. Because there is little or nowall apposition at this intermediate diameter, it is possible to make refinements in the stent graft positioning. If required, it is also possible to modify the C-arm gantry angle to remove device parallax and maximize every millimeter of the landing zone. Removal and actuation of the secondary deployment handle opens the device to its full diameter. A lock wire secures the stent graft to the catheter, ensuring that the user maintains control of the device and its positioning throughout the procedure until the lock wire is removed as one of the final deployment steps. Angulation of the proximal end of the stent graft is an optional feature that allows for more orthogonal placement of the stent graft. The benefit of angulation becomes evident in angulated aortic arch anatomies, where the wall apposition along the inner aortic curvature can sometimes lead to the formation of a bird beak. The GORE® ACTIVE CONTROL System allows the user to adjust the angulation and orthogonal placement of the proximal end of the stent graft in situ, depending on the individual anatomic needs of the patient. Angulation control is possible during the two phases of deployment, at intermediate diameter and after the stent graft has expanded to its full diameter (Fig. 4). Because this is an optional feature, the clinician can decide during deployment whether and to what degree angulation is beneficial in that specific anatomy. 9 Fig. 4 — The optional angulation feature can be used at both intermediate (a) and full (b) diameter stages. By nesting the stent rows along the inner aortic curve, angulation helps to achieve orthogonal device placement in tight arches. Fig. 3 — (a) Staged deployment allows the device to first be opened to an intermediate diameter along its entire length while ensuring continuous blood flow. (b) A separate deployment step expands the device to its full diameter.
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