It said the operation “was performed by the team headed by heart surgeon Dr Ciro Maiello at the Azienda Ospedaliera dei Colli hospital in Naples, one of the centres with the greatest experience in the field of artificial hearts in Italy”.

The company secured a European CE marking in December for sale of the Aeson prosthetic heart as a “bridge to transplant”. That certification was based on results from a study known as Pivotal, which was launched in 2016 and is still under way.

In November 2019, results from the first 11 patients in the study showed that 73% survived for six months with the prosthetic or made it to a successful transplant within the same period.

Carmat said the first commercial sale of its artificial heart marked “a major milestone that opens up a new chapter in the company’s development”, adding that it hoped to find more customers in France and Germany by the end of the year.

A spokeswoman said it was the first time one of the hearts had been used outside of a clinical trial.

Costs for the operation – more than €150,000 (RM747,300) – were paid by the regional health system, as Italy’s national system will not cover the treatment until it has been in use for several years.

On July 15, Carmat announced the first implantation of an Aeson heart into a patient in the United States, in a clinical study at Duke University Hospital in North Carolina.

It is searching for 10 suitable patients to take part in a study approved by the US Food and Drug Administration.