Joint Mechanical Engineering & CTI Seminar
|When/Where||1st November at 13:15 (GMT) at the 4 East Building, room 3.38|
Professor Keefe Manning The Pennsylvania State University, Department of Biomedical Engineering, United States
In Silico Predictions of Clotting and Embolization and the Challenge of Computational Simulations for Use in Regulatory Context
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.
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