One year outcomes of the United States regulatory trial of the Endurant Stent Graft System

Makaroun, Michel S.; Tuchek, Michael; Massop, Doug; Henretta, John P.; Rhee, Robert Y.; Buckley, Clifford J.; Mehta, Manish; Ellozy, Sharif H.

doi:10.1016/j.jvs.2011.03.002

Cited by 51 publications

(50 citation statements)

References 17 publications

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“…Welborn et al reported also no incidence of type IV endoleak in 108 patients treated with the AFX device. Endografts made from polyester, as the Endurant (Medtronic Inc., Santa Rosa, CA, USA) and the Incraft (Cordis Corp., Inc., Bridgewater, NJ, USA), have been related to relatively higher rates of intraoperative type IV endoleaks, 12% and 7% respectively, without any clinical sequlae in the follow-up [9,10]. …”

Section: Discussionmentioning

confidence: 99%

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Kouvelos

Nana

Bouris

et al. 2017

VSI

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PurposeThe newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder.Materials and MethodsA retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death.ResultsPrimary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18–26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34).ConclusionThe initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.

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Section: Discussionmentioning

confidence: 99%

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Kouvelos

Nana

Bouris

et al. 2017

VSI

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“…10 Therefore, an increasing number of low-profile devices have been introduced in clinical practice. 11,12 Some of these devices have been implanted in off-label conditions. However, use outside of the IFU increased the risk of type I endoleaks.…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms

Torsello

Scheinert

Brunkwall

et al. 2015

Journal of Vascular Surgery

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“…As the results of recent studies have shown, the device is safe and effective in the early treatment of aneurysmal disease of the infrarenal aorta. [15][16][17][18][19][20] The Endurant Stent Graft appears to have been successful in overcoming many of the limitations of earlier device designs. The delivery system profiles of 18-F (for 23 and 25-mm devices) and 20-F (devices up to 36 mm) are smaller than other currently available stent-grafts to facilitate introduction in significantly diseased aortoiliac segments.…”

Section: Discussionmentioning

confidence: 99%

Interdisciplinary and Translational Innovation: The Endurant Stent Graft…From Bedside to Benchtop and Back to Bedside

Arko

Jordan²,

Robaina³

et al. 2011

Journal of Endovascular Therapy

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One year outcomes of the United States regulatory trial of the Endurant Stent Graft System

Abstract: Early results of the Endurant pivotal trial are quite encouraging and suggest a safe and effective new device for the treatment of abdominal aortic aneurysms.

Cited by 51 publications

References 17 publications

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms

Interdisciplinary and Translational Innovation: The Endurant Stent Graft…From Bedside to Benchtop and Back to Bedside

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