In-Vitro Pulsatile Flow Measurement in Prosthetic Heart Valves: An Inter-Laboratory Comparison

One of the first steps in qualifying a new prosthetic valve for eventual clinical use is preclinical flow performance testing in vitro... ...This collaborative effort between heart valve manufacturers and the Food and Drug Administration (FDA) was designed to evaluate the variability of the pulse duplicator test technology for pulsatile flow performance measurement in an interlaboratory round robin... ...A commercially available duplicator, the Vivitro system (Vivitro, Inc., Vancouver, Canada), was used at two centers. The design specifications are summarized in Table I....