Carmat artificial heart failure implant prosthetic

artificial heart

"LifeTec Group™ was able to contribute in the assessment of potential hemolysis generated by total artificial heart developed by Carmat.

Carmat obtained the required data and now announces FDA full approval to initiate US clinical feasibility study of its total artificial heart."

The platform

Since there is no clear and full experimental test environment for blood damage, it is not straightforward to collect such data.

However, Carmat had observed that LifeTec Group™ has a rather similar model that might be used for this purpose: the PhysioHeart™ platform is a beating heart platform that runs on blood and the beating heart might be exchanged for the Carmat device to at least partially study blood damage.

Furthermore, Ventricular Assist Devices (VAD’s) had already been applied in the PhysioHeart™ platform, and therefore comparative data might be collected.

And so, Carmat contacted LifeTec Group™ with the request to support them in performing ex-vivo experiments in order to obtain the missing data.

Carmat device tested in LifeTec Group lab and platform

What was done

A full analysis of blood damage and damage markers was not really feasible, but determining hemolysis generated by the Carmat device (which is one of the important aspects needed to prove the hemocompatibility of the prosthesis) was determined to be possible.

LifeTec Group™ was able to develop a test platform with a minimal blood volume and minimal surface area but incorporating a complete full-blood circulation model in which Carmat’s total artificial heart as well as competitive devices could be incorporated.

For each of the experiments, fresh whole blood of slaughterhouse pigs was obtained and blood samples were taken at different time points covering the total experimental duration of 6 hours from which the rate of hemolysis over time could be obtained.

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