For the first time since 2008, a French prosthetics maker named Carmat has recently sold its artificial heart to an Italian patient who has been awaiting a transplant since they produced it.
According to a statement from the company Carmat, the operation was conducted by a team led by a heart surgeon, Dr Ciro Maiello, at the Azienda Ospedaliera dei Colli hospital in Naples.
The document further revealed that the company secured an European CE marking in December 2020 for the sale of the Aeson prosthetic heart as a “bridge to transplant”.
That certification was based on results from a study known as PIVOTAL, launched in 2016 and still under way.
In November 2019, results from the first 11 patients in the study showed that 73 per cent survived for six months with the prosthetic or made it to a successful transplant within the same period.
Carmat said that 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 spokesman for the company told Agence France-Presse (AFP) that it was the first time one of the hearts had been used outside of a clinical trial.
Costs for the operation—more than 150,0000E Euros ($177,000)—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 15 July, Carmat had announced the first implantation of an Aeson heart into a patient in the US, in a clinical study at Duke University Hospital in Durham, North Carolina.
It is searching for 10 suitable patients to take part in a study approved by the US Food and Drug Administration.