The French prosthetics maker Carmat said Monday it had sold an artificial heart for the first time since its founding in 2008, to an Italian patient awaiting a transplant. An artificial heart was implanted by the team led by Dr. Ciro Maiello at the Azienda Ospedaliera dei Colli hospital in Naples, one of the top centres in Italy for artificial hearts, Carmat said in a statement.
The Aeson prosthetic heart will be CE marked by December 2020, making it a ‘bridge to transplant’. A study known as PIVOTAL, launched in 2016 and still ongoing, provided the basis for that certification. According to results from the first 11 patients in the study, 73 per cent survived for six months or made it to a successful transplant within that time frame.
In a statement, Carmat said that the first commercial sale marked ‘a major milestone in the company’s growth’, adding that it hoped to find more customers in France and Germany by the end of the year. According to AFP, it was the first time one of the hearts was used outside of a clinical trial.
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More than 150,000 euros ($177,000) of the operation’s cost was covered by the regional health system, because Italy’s national health system will not pay for the treatment until it has been in use for several years. Carmat announced on July 15 that the first Aeson heart had been implanted into a patient in the United States, during a clinical study at Duke University Hospital in Durham, North Carolina. This company is looking for ten patients to take part in a study that was approved by the US Food and Drug Administration.
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