Heart Valve Testing
BDC Laboratories heart valve testing activities are directed through the ISO 5840 guidance document for surgically implanted and transcatheters heart valves. BDC’s principals actively participate in the AAMI Cardiac Valve Prosthesis Committee, the US group supporting the ISO valve standard activities. From this foundation, BDC Labs offer Hydrodynamic Performance Testing (ISO 5840 Annex L), Durability Testing (ISO 5840 Annex M), and Fatigue Testing (ISO 5840 Annex O) services. Furthermore, all heart valve testing activities can be executed per Good Laboratory Practices (GLP) and audited with our established quality assurance program.
Heart Valve Hydrodynamic Testing
From our extensive background in experimental fluid dynamics and hemodynamics, BDC’s hydrodynamic testing utilizes a dual chamber heart valve test system to accurately emulate the hemodynamics of ventricle and atrial muscle contraction and relaxation with an extremely stable flow field that meets ISO 5840 requirements for assessment and performance of aortic and mitral heart valves. BDC’s team has the expertise in conducting hydrodynamic testing activities of the device parameters of interest, such as pressure differences, effective orifice area, regurgitant volumes, and leakage rates, for both surgically implanted and transcatheter heart valve devices in a focused and efficient manner. Learn more about our HDT-200 hydrodynamic test system »
Heart Valve Durability and Fatigue Testing
Designed to meet the ISO 5840 testing requirements for both transcatheter and surgical heart valves, our test system utilizes a unique patent pending drive system, coupled to our proprietary Statys™ closed-loop control and monitoring software to facilitate pressure loading at accelerated frequencies creating an accelerated test environment that more closely emulates clinical performance. The VDT-3100 test system has the ability to test different size heart valves during the same test activity across the eight test stations, while providing continual real-time monitoring and data recording in all test stations for each sample. BDC's system allows for individual programmable test station safeguards and alarms throughout the entire 200-600 million cycle test. High Speed Imaging of each test sample can be performed via the Aortic Aspect or Perpendicular Views. Learn more about our VDT-3100 heart valve test system »
Heart Valve Simulated Use Testing
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. Some of the key device attributes that can be evaluated with simulated use testing are; pulsatile flow device interactions, cardiac device implant positioning, implant deployment accuracy, implant sizing, conformability of the implant to the vessel wall, and delivery system trackability, pushability, torquability, and heart valve in valve deployment. Learn more about our simulated use test systems »