Simulation Testing
Simulation testing provides the ability to study critical endovascular and heart valve device characteristics and design parameters in a predictable, controlled, and reproducible manner to demonstrate how a device may perform in-vivo.
BDC Laboratories’ simulated use test systems aid in the evaluation of product designs and delivery system parameters by accurately emulating physiological hemodynamics and vascular and/or cardiac anatomy and compliance. Some key device attributes that can be evaluated with BDC’s simulated use systems include: pulsatile flow device interactions, endovascular and cardiac device implant positioning, implant deployment accuracy, implant sizing, conformability of the stent graft or stent implant to vessel wall, delivery system trackability, pushability, torquability, deployment force, and heart valve in valve deployment. Furthermore, simulated use testing for delivery systems within BDC’s systems follows the requirements as outlined in the ISO-25539 and ISO-5840 guidance documents.
Simulated Use Test Systems
BDC Laboratories designs and builds custom “turn-key” simulated use systems that include clinically relevant vascular pathways while accurately achieving the appropriate hemodynamics within the model. The test system vascular pathway is typically constructed to specific clinical data using BDC’s silicone mock vessel technology; however, the systems can be compatible with other models as required. The PD-1100 pulse duplicator acts as the heart in BDC’s simulated use systems, initiating and controlling the pulsatile fluid dynamics. To facilitate system control and monitoring, as well as data collection for analysis, BDC’s Statys™ software package accompanies the test system.
