Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing Jeffrey P. Carpenter, MD, Robert Cuff,

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Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing Jeffrey P. Carpenter, MD, Robert Cuff, MD, Clifford Buckley, MD, Christopher Healey, MD, Sajjad Hussain, MD, Michel M.P.J. Reijnen, MD, Jose Trani, MD, Dittmar Böckler, MD Jeffrey P. Carpenter, MD, Jose Trani, MD, Paul Hayes, MD, Satish Muluk, MD, Javier Vasquez, MD, Clifford Buckley, MD, Neal Hadro, MD, Steven Lalka, MD, Ralph Ierardi, MD, Daniel Clair, MD, Cheong Jun Lee, MD, Homayoun Hashemi, MD, Christopher Healey, MD, Nelson Bernado, MD, James Benenati, MD, Steve Tyndall, MD, Mitchell Silver, DO, Stephen Murray, MD, Michel Reijnen, MD, PhD, Stuart Harlin, MD, John Lane, MD, Robert Cuff, MD, Nikhil Kansal, MD, Zvonimir Krajcer, MD, Kevin Bruen, MD, Sajjad Hussain, MD, Luis Leon, MD, Dittmar Böckler, MD, PhD, Michel Makaroun, MD, Jeffrey Indes, MD Jeffrey P. Carpenter, MD, Robert Cuff, MD, Clifford Buckley, MD, Christopher Healey, MD, Sajjad Hussain, MD, Michel M.P.J. Reijnen, MD, Jose Trani, MD, Dittmar Böckler, MD Jeffrey P. Carpenter, MD, Jose Trani, MD, Paul Hayes, MD, Satish Muluk, MD, Javier Vasquez, MD, Clifford Buckley, MD, Neal Hadro, MD, Steven Lalka, MD, Ralph Ierardi, MD, Daniel Clair, MD, Cheong Jun Lee, MD, Homayoun Hashemi, MD, Christopher Healey, MD, Nelson Bernado, MD, James Benenati, MD, Steve Tyndall, MD, Mitchell Silver, DO, Stephen Murray, MD, Michel Reijnen, MD, PhD, Stuart Harlin, MD, John Lane, MD, Robert Cuff, MD, Nikhil Kansal, MD, Zvonimir Krajcer, MD, Kevin Bruen, MD, Sajjad Hussain, MD, Luis Leon, MD, Dittmar Böckler, MD, PhD, Michel Makaroun, MD, Jeffrey Indes, MD Journal of Vascular Surgery Volume 63, Issue 1, Pages 23-31.e1 (January 2016) DOI: 10.1016/j.jvs.2015.07.096 Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 1 Nellix EndoVascular Aneurysm Sealing (EVAS) system. Each Nellix device (A) includes a balloon-expandable cobalt-chromium alloy stent jacketed in expanded polytetrafluoroethylene and surrounded by a polyurethane endobag. Two Nellix devices are deployed in “kissing stent” fashion, ensuring proximal stent alignment, after which polymer is introduced under pressure monitoring to the endobags (B). The delivery system catheter (C) outer sheath is 17F in profile (outer diameter). A console (D) attaches to two Nellix catheters to facilitate simultaneous endobag preparation, stent deployment, polymer filling, and angiography. An in-line pressure transducer is used to monitor pressure during prefill and polymer fill. Journal of Vascular Surgery 2016 63, 23-31.e1DOI: (10.1016/j.jvs.2015.07.096) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 2 Computed tomography (CT) appearance of an abdominal aortic aneurysm (AAA) before (A) and 30 days after (B) treatment with the Nellix EndoVascular Aneurysm Sealing (EVAS) device. The enhanced preoperative CT scan shows an AAA with a large flow lumen and mural thrombus. After treatment with the Nellix device (B), CT scan shows residual contrast material within the polymer-filled endobags. The outlines of the two endobags and the two stents are clearly visible. Journal of Vascular Surgery 2016 63, 23-31.e1DOI: (10.1016/j.jvs.2015.07.096) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 3 Preservation of the hypogastric artery in an abdominal aortic aneurysm (AAA) patient with concomitant common iliac artery aneurysmal disease. Arteriograms performed before (A) and after (B) endovascular aneurysm sealing (EVAS) with the Nellix system are shown. Journal of Vascular Surgery 2016 63, 23-31.e1DOI: (10.1016/j.jvs.2015.07.096) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 4 Type Ia endoleak on 30-day computed tomography angiography (CTA). The proximal attachment leak is located posteriorly. Contrast in the endoleak (arrows) and in the graft limbs appears much brighter than the residual contrast contained in the polymer-filled endobags. Journal of Vascular Surgery 2016 63, 23-31.e1DOI: (10.1016/j.jvs.2015.07.096) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 5 Type II endoleaks. Lumbar to lumbar endoleaks with volumes of 0.4 mL (A) and 0.1 mL (B) are shown (arrows). Faint residual contrast is seen in the polymer within the endobags while bright contrast appears in the regions of blood flow within the graft limbs, in the lumbar arteries, and in the limited endoleak space. Journal of Vascular Surgery 2016 63, 23-31.e1DOI: (10.1016/j.jvs.2015.07.096) Copyright © 2016 Society for Vascular Surgery Terms and Conditions