French company Carmat sells first artificial heart to Italian patient

A French prosthetics company announced on July 19, that it sold its first artificial heart. Carmat, the French company, announced that its artificial heart was bought and transplanted into an Italian patient.

Carmat stated that the procedure “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.”
The artificial heart, marketed as the Aeson prosthetic heart, got the certification to be sold in the European Union in December 2020. The certification for the French company, which was founded in 2008, came based on the PIVOTAL research that had started in 2016 and which is still ongoing.
Carmat said the sale of the Aeson heart signified “a major milestone that opens up a new chapter in the company’s development.” The company also added that it was looking to help more customers in France and Germany by the end of the year. The artificial heart helps patients who need immediate transplants but have to wait for the relevant organs. According to a study in 2019, 73 percent of the patients survived the transplant for six months or until a successful permanent transplant within the same period.
While the treatment may prove to be lifesaving, the costs may be prohibitive. The surgical operation cost over 150,000 euros, which was paid for by the regional health system. The national system in Italy will not cover the procedure until it has been proven to be safe over several years.

Artificial Hearts Are Now Produced Industrially

Carmat (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, has announced the certification of its new manufacturing site situated in Bois-d’Arcy, near Paris. In line with the schedule, the recently opened automated site is perfectly aligned with Carmat’s strategic transformation into an industrial company.

The newly available space will allow the production of up to 800 units per year at full capacity to meet the demands of industrial-pace manufacturing as well as the enrollment ramp up in the ongoing PIVOTAL study. Furthermore, this facility will enable the use of new tools, such as robots, to assemble hybrid membranes on the device and a fully-automated software station to set up the prosthesis parameters. This project has been conducted by a dedicated team with the aim to implement best industrial practices in regards to the organization, processes, and IT systems for maximum efficiency and quality.

Stéphane Piat, Chief Executive Officer of Carmat, commented: “We are delighted to announce the certification of our new manufacturing site based in Bois-d’Arcy, near Paris, which is a true accomplishment as we have achieved it in less than a year from the start of the building construction. Carmat will now be able to manufacture products in both Vélizy and Bois-d’Arcy. In line with our strategy, the new automated site will enable Carmat to become an industrial company with the ability to manufacture up to 800 units a year at full capacity in order to support the demand. Thanks to new processes, we will increase production throughput and more importantly, reinforce the quality of our prostheses to better serve patients across the world.”