a method to determine the kink resistance of stents and stent delivery systems according to international standards

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ID: 200381
2016
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Abstract
The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius.
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Authors ;Brandt-Wunderlich Christoph;Schwerdt Christopher;Behrens Peter;Grabow Niels;Schmitz Klaus-Peter;Schmidt Wolfram
Journal materials science and engineering c
Year 2016
DOI
10.1515/cdbme-2016-0064
URL
http://www.degruyter.com/view/j/cdbme.2016.2.issue-1/cdbme-2016-0064/cdbme-2016-0064.xml?format=INT
Keywords
fda standard delivery system

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