In Vitro models for thrombogenicity testing of blood-recirculating medical devices.

INTRODUCTION

Blood-recirculating medical devices, such as mechanical circulatory support (MCS), extracorporeal membrane oxygenators (ECMO), and hemodialyzers, are commonly used to treat or improve quality of life in patients with cardiac, pulmonary, and renal failure, respectively. As part of their regulatory approval, guidelines for thrombosis evaluation in pre-clinical development have been established. testing evaluates a device's potential to produce thrombosis markers in static and dynamic flow loops.

AREAS COVERED

This review focuses on static and dynamic models to assess thrombosis in blood-recirculating medical devices. A summary of key devices is followed by a review of molecular markers of contact activation. Current thrombosis testing guidance documents, ISO 10993-4, ASTM F-2888, and F-2382 will be discussed, followed by analysis of their application to testing models.

EXPERT OPINION

In general, researchers have favored models to thoroughly evaluate thrombosis, limiting evaluation to hemolysis. studies are not standardized and it is often difficult to compare studies on similar devices. As blood-recirculating devices have advanced to include wearable and implantable artificial organs, expanded guidelines standardizing testing are needed to identify the thrombotic potential without excessive use of resources during pre-clinical development.