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A novel in vitro model for preclinical testing of the hemocompatibility of intravascular stents according to ISO 10993-4

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Abstract

Subacute stent thrombosis, caused by undesired interactions between blood and the stent surface, is a major concern in the first few weeks following coronary artery stent implantation. The aim of this study was to establish a novel in vitro model for hemocompatibility testing of coronary artery stents according to ISO 10993-4. The model consists of a modified Chandler-Loop design with closed heparin-coated PVC Loops and a thermostated water bath. The tests were performed with anticoagulated human whole blood. After incubation in the loop, blood was analyzed for coagulation and inflammatory activation markers (TAT, β-TG, sP-selectin, SC5b-9 and PMN-elastase). Three different stent types with varying thrombogenicity were tested; statistically significant differences were found between the three stent types in measures of coagulation and platelet activation. The new Chandler-Loop model can be used as an alternative to animal and current in vitro models, especially for the determination of early events after stent implantation.

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Acknowledgments

The authors thank Karl-Heinz Hellmer for the excellent support during the SEM procedures. Tests and stent delivery systems were sponsored by Boston Scientific Corporation, Natick, MA, USA. Furthermore the authors thank Barbara A. Huibregtse and Michael J. Eppihimer (Boston Scientific Corporation, Pre-clinical department, 1 Boston Scientific Place, Natick, MA 01760 USA), Kristin L. Hood (Boston Scientific Corporation, Scientific communications, 100 Boston Scientific Way, Marlborough, MA 01752-1234 USA) and Nic Van Dyck (Boston Scientific Corporation, Clinical department, Gaetano Martinolaan 50, 6229 GS Maastricht Netherlands) for their valuable work of reviewing the manuscript.

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Authors and Affiliations

  1. Division of Congenital & Pediatric Cardiac Surgery, University Children’s Hospital, Clinical Research Laboratory, Calwerstr. 7/1, 72076, Tubingen, Germany

    Stefan Sinn, Stephan Deichelbohrer, Gerhard Ziemer & Hans P. Wendel

  2. Boston Scientific Technologie Zentrum GmbH, Perchtinger Strasse 6, 81379, Munich, Germany

    Torsten Scheuermann

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  1. Stefan Sinn
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  2. Torsten Scheuermann
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  3. Stephan Deichelbohrer
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  4. Gerhard Ziemer
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  5. Hans P. Wendel
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Correspondence to Hans P. Wendel.

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Sinn, S., Scheuermann, T., Deichelbohrer, S. et al. A novel in vitro model for preclinical testing of the hemocompatibility of intravascular stents according to ISO 10993-4. J Mater Sci: Mater Med 22, 1521–1528 (2011). https://doi.org/10.1007/s10856-011-4335-2

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  • DOI: https://doi.org/10.1007/s10856-011-4335-2

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