Preclinical Device Thrombogenicity Assessments: Key Messages From the 2018 FDA, Industry, and Academia Forum

Device-related thrombosis and thromboembolic complications remain a major clinical concern and often impact patient morbidity and mortality. Thus, improved preclinical thrombogenicity assessment methods that better predict clinical outcomes and enhance patient safety are needed. However, there are several challenges and limitations associated with developing and performing preclinical thrombogenicity assessments on the bench and in animals (e.g., the clinical relevance of most in vitro tests has not been established, animal studies may not accurately predict clinical thrombotic events). To facilitate a discussion on how to overcome some of these challenges and to promote collaboration between the Food and Drug Administration (FDA), industry, and academia for the development of more reliable test methods, a scientific forum was organized by FDA and held in Washington, DC, on June 15, 2018 at the ASAIO 64th Annual Conference. Three subject matter experts from the medical device industry and FDA presented their perspectives at this forum, and several audience experts provided input during the open dialogue session. This article summarizes the key messages from the forum regarding the current status and challenges of preclinical thrombogenicity testing, important areas of needed research, and mechanisms for working with FDA to further improve thrombogenicity evaluations of medical devices.