French company makes first sale of “artificial” heart, World News
The French manufacturer of prostheses Carmat announced Monday that it had sold one of its artificial hearts for the first time since its creation in 2008, to implant it in an Italian patient awaiting a transplant.
The operation “was carried out by the team led by cardiac surgeon Dr Ciro Maiello at the Azienda Ospedaliera dei Colli Hospital in Naples, one of the centers with the greatest experience in the field of artificial hearts in Italy”, Carmat said in a statement.
The company obtained a European CE mark in December 2020 for the sale of the Aeson prosthetic heart as a ‘bridge to transplantation’.
This certification was based on the results of a study known as PIVOTAL, launched in 2016 and still ongoing.
In November 2019, the results of the first 11 patients in the study showed that 73% survived for six months with the prosthesis or were successful in a transplant during the same period.
Carmat said the first commercial sale of her artificial heart marks “a major milestone that opens a new chapter in the company’s development”, adding that she hopes to find more customers in France and Germany by the end. of the year.
A spokesperson told AFP it was the first time that one of the hearts has been used outside of a clinical trial.
The costs of the operation – more than 150,000 euros ($ 177,000) – were paid by the regional health system, as Italy’s national system will only cover the treatment when it has been in use for several years.
On July 15, Carmat announced the first implantation of an Aeson heart in a patient in the United States, as part of a clinical study at Duke University Hospital in Durham, North Carolina.
She is looking for 10 suitable patients to participate in a study approved by the United States Food and Drug Administration.