This is the first sale of the company since its creation, in 2008. The French company Carmat announced, Monday, July 19, to have marketed for the first time its total artificial heart, under the Aeson brand, in Naples. It is implanted on a patient in order to act as a relay while waiting for a transplant.
The operation was “Carried out by the team of Dr Ciro Maiello, cardiac surgeon at the hospital center of Naples, one of the centers with the greatest experience in the field of artificial hearts in Italy ”, says the company in a press release. For Carmat, this location represents “A major step, which opens a new page in the development of the company”.
A first establishment in the United States
In December 2020, Carmat obtained the CE marking in Europe, a sign of its compliance with the requirements of European Union community regulations. This indicator will thus have given him the green light for the sale of his artificial heart in Europe as a bridge to transplantation for patients awaiting a transplant. The company had received the said marking thanks to positive intermediate results vis-à-vis its comparative efficacy study, which began in 2016 and is still ongoing to this day.
On July 15, the French medical technology company announced that it had implanted, for the first time, in the United States, a total artificial heart, as part of a clinical study carried out within the framework of Duke University Hospital, in Durham, North Carolina.
Ten patients eligible for transplantation must be recruited into this trial, according to the study protocol approved by the Food and Drug Administration. Three other US centers are currently selecting patients for the study.