Thrombogenicity testing is a requirement for regulatory approval of blood-contacting medical devices [1]. Although in vivo assessments, typically using the nonanticoagulated venous implant (NAVI) model, are often part of submission packages, there is a need for faster and cheaper assays including in vitro screening models [2]. Currently, there is enthusiasm within the FDA for expanding the efforts to develop validated in vitro models [3]. With more characterization effort and regulatory review, these models can be utilized at the time of device design and materials optimization to improve or replace the more expensive and less predictive in vivo models [4]. The key characteristics of successful in vitro models include fresh blood, low levels of anticoagulation, flow conditions with shear stress, and minimization of air/blood interfaces. This model integrates freshly harvested ovine blood containing minimal levels of heparin with...

References

References
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