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

• Main Authors: Brandt-Wunderlich Christoph, Schwerdt Christopher, Behrens Peter, Grabow Niels, Schmitz Klaus-Peter, Schmidt Wolfram
• Format: Article
• Language: English
• Published: De Gruyter 2016-09-01
• Series: Current Directions in Biomedical Engineering
• Subjects: delivery system; fda; iso; kink resistance; standard; vascular stents
• Online Access: https://doi.org/10.1515/cdbme-2016-0064
• ISSN: 2364-5504

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.