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The use of Endurant stent-graft for abdominal aortic aneurysm: the story about extension of Instruction for Use with persistent good results of stent-graft latest generation


Rancic, Z; Pecoraro, F; Pfammatter, T; Banzic, I; Klein, H; Kyriakidis, K; Mayer, D; Lachat, M (2012). The use of Endurant stent-graft for abdominal aortic aneurysm: the story about extension of Instruction for Use with persistent good results of stent-graft latest generation. Journal of Cardiovascular Surgery, 53(5):579-594.

Abstract

The Endurant stent-graft (Medtronic, Inc., Minneapolis, MN, USA) is a latest generation device for the treatment of abdominal aortic aneurysm. The idea behind designing such a graft came from the intention to broad the instruction for use (IFU) and to enable it to treat more challenging anatomy including the 10mm neck lengths, and more severe suprarenal and infrarenal angulations. Endurant stent-graft has active fixation through suprarenal stent with anchoring pins to provide migration resistance, optimized heights of stents and spacing between them for improved flexibility and conformability, low-profile delivery system with hydrophilic coating and controlled simple deployment mechanism. Short term results are excellent. Technical and clinical success is confirmed in Regulatory trials (EU and USA), as well as in ENGAGE and the Canadian registry. Many current publications record the use of Endurant stent-graft outside the Instruction for use. The results in a group of patients outside the instruction for use are comparable to those within instruction for use; with the exception of perioperative proximal endoleak type I. Mid-term results are consistent with short-term results. The long-term results are lacking.

Abstract

The Endurant stent-graft (Medtronic, Inc., Minneapolis, MN, USA) is a latest generation device for the treatment of abdominal aortic aneurysm. The idea behind designing such a graft came from the intention to broad the instruction for use (IFU) and to enable it to treat more challenging anatomy including the 10mm neck lengths, and more severe suprarenal and infrarenal angulations. Endurant stent-graft has active fixation through suprarenal stent with anchoring pins to provide migration resistance, optimized heights of stents and spacing between them for improved flexibility and conformability, low-profile delivery system with hydrophilic coating and controlled simple deployment mechanism. Short term results are excellent. Technical and clinical success is confirmed in Regulatory trials (EU and USA), as well as in ENGAGE and the Canadian registry. Many current publications record the use of Endurant stent-graft outside the Instruction for use. The results in a group of patients outside the instruction for use are comparable to those within instruction for use; with the exception of perioperative proximal endoleak type I. Mid-term results are consistent with short-term results. The long-term results are lacking.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Diagnostic and Interventional Radiology
04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:26 Sep 2012 10:01
Last Modified:05 Apr 2016 15:58
Publisher:Edizioni Minerva Medica
ISSN:0021-9509
Related URLs:http://www.minervamedica.it/en/journals/cardiovascular-surgery/archive.php (Publisher)
PubMed ID:22955553

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