METHOD FOR THROMBOGENICITY TESTING OF IMPLANTED MEDICAL DEVICE

摘要

A method of determining the thrombogenicity of an implantable medical device is disclosed. The implanted device is exposed in vitro to platelet rich plasma, the activity of an indicator is assayed, and the thrombogenicity is determined.

主权项

1. A method for determining thrombogenicity of an implanted medical device comprising:
introducing the medical device in a testing device; exposing the medical device to circulating volume of platelet rich plasma (PRP) in a closed system testing device, the PRP comprising factors of thrombosis; determining levels of thrombogenic indicators including at least one of LDH and D-dimer and platelet adhesion on the medical device; and correlating the levels of thrombogenic indicator(s) to determine thrombogenicity of the medical device based on the indicator from platelet adhesion on the medical device.