American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs.
Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for sale and distribution. Key among these requirements is the need for hemocompatibility testing, governed by the international standard ISO-10993-4 – recently updated to reflect some of the most recent advances in the science of blood compatibility.
the In-vitro Blood Loop Assay – utilizes blood from donor sheep pumped through a closed tubing loop, which simulates the circulation in the animal. The test and comparator devices (up to nine of each, allowing statistical assessment of endpoints) are deployed in the flowing blood for a similar duration of about four hours, after which the devices are removed and quantitatively evaluated for the presence of blood clots in a manner similar to that used in the NAVI model.
American Preclinical Services (APS) has been awarded AAALAC’s 2017 Global 3Rs Award for North America – a significant acknowledgement from a well-respected external organization that APS’s ongoing efforts to redesign thrombogenicity testing can have a global impact. The end-goal is to significantly enhance the accuracy and performance of thrombogenicity testing and substantially reduce the number of research animals used to accomplish these goals.
At the very least, the approval of this test method by the FDA will provide medical device manufacturers and other contract research organizations a superior alternative method for testing that is acceptable for use in manufacturers’ submissions to regulatory bodies for approval.