Multicenter pivotal trial results of the Lifepath System for endovascular aortic aneurysm repair

Lifepath System is a balloon-expandable, modular stent graft consisting of a main body (A) and docking limbs (not shown). Proximal and distal extension cuffs in various sizes are available. Grafts are premounted on balloons that have square shoulders, and are also supplied separately. Stent grafts are delivered through flexible, hydrophilic sheaths supplied in 25F and 19F (OD) sizes. B, A directional catheter, shown with a cut-away view of the main body stent graft, facilitates cannulation of the contralateral limb by means of a moveable tip, which can be deflected with a hand control located at the back of the catheter.

Device insertion procedure (see text for details). A, Main body deployment. The two legs of the main graft body are self-expanding. B, Iliac limb deployment with balloon inflation.

Kaplan-Meier analysis of anchoring wireform fractures for first-generation and second-generation Lifepath System.

Abdominal aortic aneurysm diameter and volume change after endovascular aortic aneurysm repair. Reduction in diameter and volume is significant at each follow-up. Mean (± SE) aneurysm diameter decreased by 3 mm at 6 months (P < .0001), an additional 7 mm at 12 months (P < .0001), and an additional 3 mm at 24 months (P < .0001). Similarly, mean (± SE) aneurysm volume decreased by 15 mL at 6 months (P = .0012), an additional 28 mL at 12 months (P < .0001), and an additional 12 mL at 24 months (P = .0002). See Table VII for details of diameter and volume change at each follow-up.