An artificial heart was sold for the first time by Carmat, a French prosthetics maker. The artificial heart was sold for implantation into a patient from Italy awaiting a heart transplant. This was the first sale of Carmat's artificial heart since its founding in 2008.
The company, in a statement, said that Dr. Ciro Maiello, a cardiac surgeon, led the team operating at Azienda Ospedaliera dei Colli hospital in Naples, Italy. Azienda Ospedaliera dei Colli hospital is a center with exceptional expertise in the field of artificial hearts.
The Aeson prosthetic heart developed by Carmat received European CE marking for its sale in December 2020. The CE marking was given to the Aeson heart as a 'bridge to transplant'. Results from the ongoing PIVOTAL study initiated in 2016 served as the basis for this certification.
A successful transplant or survival for six months post the implant was seen in 73 % of the first 11 patients involved in the study. The study results were noted in November 2019.
The first commercial sale of the Aeson prosthetic heart marked a significant milestone for the company and began a new chapter in its development. By the end of the year, the company hopes to find more customers in Germany and France, said Carmat.
This artificial heart transplant marked the outside clinical trial usage of a heart for the first time, said a spokeswoman.
The operation incurred a cost of more than 150,000 euros ($177,000). However, Italy's national health system does not cover the charge of treatment unless it has been in practice for several years. Therefore, the regional health system covered the expense of the transplantation.
The first Aeson heart implant under a clinical study was announced by Carmat on July 15. This implant was performed at Duke University Hospital in Durham, North Carolina, on a US patient.
The company is looking for about ten eligible patients for a study approved by the US Food and Drug Administration.