NNA – French prosthetics maker Carmat said on Monday (July 19) it had sold one of its artificial hearts for the first time since its 2008 founding, for implantation into an Italian patient awaiting a transplant.
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”, Carmat said in a statement.
The company secured a European CE marking in December 2020 for sale of the Aeson prosthetic heart as a “bridge to transplant”.
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health and environmental protection requirements.
Carmat’s certification was based on results from a study known as PIVOTAL, launched in 2016 and still under way.
In November 2019, results