Development of a new in vitro model for studying implantable polyurethane calcification.

The objective of this study was to reproduce mineralization of polymeric substrate in an extracirculatory environment which would facilitate investigation of the calcification mechanism in implantable biomaterials and methods of prevention. Calcification was examined on polyurethane films incubated in metastable solutions of calcium phosphate and the role of strain, serum and polymer porosity was examined. Validation of the model was evaluated by examining the calcification of both highly calcifiable biomaterial (bioprosthetic tissue) and a non-calcifiable biomaterial (charge-modified tissue and polyurethane containing anticalcification agent). It is concluded that the developed model is adequately sensitive to diagnose biomaterials' propensity to calcify and could serve as a pre-screening method to examine calcification mechanism and methods of prevention.