This presentation will cover two subjects. First, blood clotting is a major clinical issue that can adversely impact cardiovascular device performance but also whether associated with these devices or not, can lead to strokes, pulmonary embolism, or heart attacks. Mathematical models of clot growth have been established, but there is little known about the mechanical forces that are required to dislodge a clot from its anchor point. Detailed mechanical knowledge on the adhesive forces holding a clot to a surface would prove helpful in building the next generation of computational models of embolization, potentially allowing for a more in-depth understanding of embolization fluid dynamics. This part of the presentation will cover my group’s work in developing and validating a clot growth and embolization model.
The second part of the presentation will cover the challenges that exist for in silico models to demonstrate cardiovascular device performance as part of a regulatory submission. Since there is increasingly more research performed computationally, there is a necessity to demonstrate that the simulations are appropriately validated. Specifically, with regard to medical devices, the United States Food and Drug Administration (FDA) has experienced an increased number of applications with computational simulations attempting to demonstrate that the technology to be evaluated is safe and effective. The FDA has developed benchmark models to evaluate the abilities for computational researchers to predict the flow and eventually the blood damage in flows such as a nozzle and centrifugal pump. In this part of the presentation, previous and ongoing studies between the FDA and experimental labs will be highlighted with particular emphasis on the barriers that exist to prove technology is safe and effective from a blood damage perspective.
Dr. Keefe B. Manning is a Professor of Biomedical Engineering and Professor of Surgery (courtesy) at The Pennsylvania State University. He completed his B.S. in Bioengineering in 1995 at Texas A&M University and his M.S. in Bioengineering in 1997 at Texas A&M University. Subsequently, he completed his Ph.D. in Biomedical Engineering in 2001 at Virginia Commonwealth University studying flow in the outlet of a centrifugal blood pump. He spent 2001-2004 as a post-doctoral scholar studying the fluid mechanics of prosthetic heart valves before starting his faculty appointment in 2004. Dr. Manning and his research team study flow associated with cardiovascular devices (e.g., blood pumps, valves, IVC filters, cannulae, thrombectomy devices, and ECMO). His group also studies how clotting occurs with these devices and is developing a computational model to predict clot formation and embolization. His research has been sponsored by the National Institutes of Health, National Science Foundation, American Heart Association, U.S. Food and Drug Administration, Department of Defense, Grace Woodward Foundation, and industry. He holds fellow status in two organizations: the American Institute for Medical and Biological Engineering and the American Society of Mechanical Engineers.
I look forward to seeing you there.