Welcome to our initiative dedicated to revolutionise in vitro testing of mechanical circulatory support, in collaboration with the FDA.
Explore the details below to understand how you can be a part of this groundbreaking effort.
objective
The main objective of this international and interlaboratory Round-robin study is to create a standardised in vitro testing protocol for mechanical circulatory supports (MCSs).
In the absence of reliable, consensus-developed test methods, device manufacturers are limited to evaluating MCS devices under pressure and flow conditions using inconsistent, in-house protocols and acute animal studies. The FDA and the University of Twente will run an interlaboratory study that aims at better predicting MCS functionality before clinical use and still subject the devices to a range of pathophysiologic conditions.
Together with your contribution, we aim to define a protocol for the use of mock circulatory loops as a pre-clinical regulatory tool for accelerating patient access to high-quality, innovative, safe, and effective MCS devices and creating a more efficient regulatory decision-making process. The overall objective of the proposed project is to improve MCS device performance testing by developing well-defined, reproducible, and standardized methods that describe the use of circulatory mock loops to simulate disease states and to assess MCS interaction.
WHO CAN PARTICIPATE?
We warmly welcome any research centre or company capable of conducting in vitro hemodynamic investigations of MCSs. There are no specific eligibility criteria for participation.
Key Information for Potential Participants:
- Reduced Animal Testing: Contribute to a significant reduction in animal experiments by participating in our initiative.
- Cost and Time Efficiency: Joining our study means streamlining the assessment of MCS hemodynamic performance, leading to reduced costs and time compared to conventional methodologies.
Benefits of Participation
Participants will become integral members of an international scientific consortium focused on enhancing in vitro testing methodologies. Embrace collaboration, and knowledge sharing, and contribute to a global initiative.
how can I participate?
Join our innovative project and contribute to the improvement of MCS assessment. Together, we take steps towards a more efficient and ethically responsible approach to in vitro research on blood pumps.