Durability and particulate testing system and method

Abstract

A medical device durability and particulate testing system is provided including a durability tester component configured for continually actuating movement of structural device(s); a simulated blood fluid; fluid flow lines; a particle counter component configured for recording continuous particulate data from device(s) subjected to durability testing; flow meters; a fluid management system; and one or more system controller(s) having a processor configured with software for controlling operation of the system and recording data. In an embodiment, the system includes a user interface accessible via a display. In some embodiments the system further includes a heater paired with temperature measuring devices to maintain fluid temperatures within appropriate bounds to simulate blood within the body. In an exemplary embodiment, the durability and particulate testing system is a continuous flow, closed loop system and configured for testing synthetic structural heart devices to simulate the expected lifetime of the device(s).