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The INCRAFT ® AAA Stent Graft System : Clinical Results and Experience

ADVANCED DESIGN AND TECHNOLOGY The INCRAFT® AAA Stent Graft System (Cordis Corporation) is part of the latest generation in advanced endovascular aneurysm repair (EVAR) technology that combines and introduces unique features for the treatment of infrarenal abdominal aortic aneurysms (AAAs).1 The main body of the INCRAFT® Stent Graft is delivered through a flexible 14-F, ultra-low-profile delivery system,* allowing for proximal repositioning, and has a cap-free fixation release to assist with optimal placement accuracy. The iliac limb delivery system is equivalent to a 12-F sheath introducer.† Both the aortic bifurcation and the iliac limbs are constructed out of low-porosity polyester fabric with segmented endoskeletal nitinol stents. The stent graft design allows the highest amount of in situ sizing of all endografts currently on the market and, as such, provides a maximum level of customizability and conformability to address a wide range of AAA anatomies (Figure 1). The current clinical data confirm excellent results with the INCRAFT® System, and a postmarket study is ongoing to verify the effectiveness of this system in the real-world setting. INNOVATION TRIAL The INNOVATION first-in-human feasibility study supporting the EU CE Mark approval was started in 2010 and enrolled 60 patients in two countries and six participating centers. With 14 patients treated, the Unit of Vascular Surgery, University of Florence (Florence, Italy) was among the highest enrollers in the study and built an extensive experience in the early developments of the device. Based on the primary technical and safety endpoints at 1-month follow-up, the INCRAFT® Stent Graft System showed promising results despite a large number of patients with core lab–confirmed anatomic challenges. The most significant challenges were high infrarenal neck angulations (> 40° in 30% of patients), tight aortic bifurcations (< 18 mm in 33% of patients), and tight iliac access (< 7 mm in 45% of patients).2 The rate of technical success, defined as freedom from endoleaks, at 1 month was 97% (56/58 patients of the original 60 patients who were enrolled), with 100% of patients free from aneurysm enlargement and no type I or type III endoleaks in any patients at 2 years postprocedure.3 These favorable results were similar at 3-year followProf. Giovanni Pratesi outlines the effectiveness of a new-generation device in expanding EVAR