Investigation of hemolysis in a generic implantable device: An FDA initiative

Computational fluid simulations were developed for a generic blood-interfacing implantable device. The simulations were analyzed to determine hemodynamic behavior within the device, including velocity profiles, the magnitude of shear stress, and pressure drop. By monitoring 100 streamlines, the total blood damage induced by the device was estimated and compared to that observed for a bioprosthetic aortic valve.