A big step in research on heart disease.
For the first time, a total artificial heart from the French company Carmat was implanted in a human body on Thursday.
The implantation was performed at Duke University Hospital in Durham, North Carolina in the United States as part of a clinical study, Carmat said in a press release.
This “first American clinical study will be decisive for our development on the world's largest medical device market”, underlines Stéphane Piat, CEO of Carmat, who in the press release mentions “an exceptional step both for patients and for our society”.
"First alternative to heart transplantation"
In fact, subject to the success of clinical trials, the Carmat artificial heart could save the lives of thousands of patients every year.
The company aims to become "the first alternative to heart transplantation".
With its heart made up of the implantable bioprosthesis and the portable external power supply system to which it is permanently connected, Carmat hopes "to alleviate the notorious lack of grafts from which tens of thousands of people suffering from irreversible terminal heart failure are victims, first cause of death in the world ”.
Ten eligible patients
Three other US centers have been trained and are currently selecting patients for the study.
Ten patients eligible for transplantation should be enrolled in this trial, according to the study protocol approved by the Food and drug administration (FDA).
Carmat intends to start marketing its total artificial heart, under the Aeson brand, in the course of 2021, with a particular focus on France and Germany.
In Europe and the United States, 20 million patients suffer from heart failure.
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