ADVANCING IN VITRO MEDICAL DEVICE TESTING

Welcome to our initiative dedicated to advancing in vitro testing of mechanical circulatory support (MCS) technologies.

OBJECTIVE

The U.S. Food and Drug Administration (FDA) and the University of Twente are coordinating an international interlaboratory study aimed at developing a standardized in vitro testing protocol for mechanical circulatory support devices.

Status of the study

A total of 16 laboratories worldwide have joined this initiative.

The protocol included a range of pathophysiological conditions designed to evaluate LVAD hemodynamic performance across diverse simulated patient profiles.

Each participating laboratory used its own mock circulatory loop or hybrid simulator to test the same LVAD technology according to a predefined experimental protocol.

The data collected by each laboratory are currently being analysed to assess intra-laboratory repeatability and inter-laboratory variability.

Through this collaborative effort, we aim to establish reproducible and standardized methods for simulating clinically relevant disease states using mock circulatory loop and hybrid simulator platforms, for evaluating the hemodynamic performance of MCS devices.

In addition, the study will help identify the minimum requirements for a mock circulatory loop or hybrid simulator to serve as a reliable and reproducible test bench for LVAD technologies.

Ultimately, this initiative seeks to contribute to the development of more consistent, transparent, and reliable approaches for the preclinical evaluation of mechanical circulatory support technologies.

List of participants