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French company Carmat announced its first human artificial heart implant in the United States on Thursday, as part of a clinical study.
The total artificial heart, called Aeson, is already available in Europe, according to the company’s website.
This “first US-based clinical study will be decisive for our development in the world’s biggest market for medical devices”, Stephane Piat, Carmat’s director general, said in a statement.
The procedure took place at Duke University Hospital in Durham, North Carolina, Carmat said.
Three other centres for the study in the United States have been set up and are in the process of selecting trial candidates.
Ten eligible patients must be recruited for the US Food and Drug Administration-approved study.
The Carmat device is intended for people with end-stage heart failure, which can usually only be treated with a heart transplant.