Carmat has started the pivotal trial of the bioprosthetic artificial heart, which is being developed as a therapeutic alternative for people suffering with end-stage biventricular heart failure.
The first patient has been implanted with the bioprosthetic artificial heart in trial, as per the authorizations obtained from the ANSM (French national agency for the safety of medicines and health products) and CPP (patient protection committee).
The data from the pivotal study will be used to obtain CE mark approval.
Carmat said that it will publish information about the general progress made during the CE marking process.
Carmat is claimed to be the world’s most advanced total artificial heart project that is designed to provide solutions for the end-stage heart failure, which is expected to affect around 20 million patients in the US and Europe.
Supported by European Commission, the Carmat project has received €33m grant from Bpifrance.
Professor Alain Carpentier and Airbus Group (Matra Défense) are mainly supporting the Carmat project. Alain invented Carpentier-Edwards heart valves.
The Centre Chirurgical Marie Lannelongue, Truffle Capital, ALIAD, CorNovum, Bpifrance and the French State investment holding company CorNovum, as well as multiple institutional and individual shareholders are supporting the project.