At the end of December, the French company obtained the European certification necessary to market its artificial heart. Until now, the transplants carried out have resulted in fairly short survivals, but this device could above all be used to allow the patient to wait for a natural graft.
The Carmat company is taking a new step: its artificial heart, called “Aeson”, will be marketed from the second quarter of 2021 in the countries of the European Union. It will also be sold”in about ten countries that accept CE marking, such as Russia, Kazakhstan“, specified Stéphane Piat, managing director of the company Carmat, on France News. This marking was obtained on December 22.
Marketing in Germany and France
The entrepreneur hopes to be able to quickly produce ten artificial hearts per month, knowing that it takes on average a year to be able to design one. “In 2021, the company plans to focus on Germany and France, which together account for 55% of the Mechanical Circulatory Support Devices (MCS) market in the European Union“, specifies a communicated published by Carmat. Five centers French university hospitals (CHU) will have this technology available: Pitié-Salpêtrière in Paris and the CHUs of Lyon, Lille, Toulouse and Rennes. Marketing will be followed by new clinical studies. In France, the PIVOT study, started in 2016, is still ongoing. The various results will make it possible to estimate the coverage provided by the Health Insurance.
Reduced survival, compared to a natural graft
The first artificial heart was implanted in December 2013, in a French patient. The latter had survived two and a half months. The four other people who underwent the operation all died. From 2017, trials were carried out in Kazakhstan. The Food and Drug Administration, in the United States, gave its approval for clinical work on its territory in February 2020. According to the various results, only one patient survived more than two years after the implantation of the artificial heart. The clinical trial showed that 73% of patients survived at least six months after the operation. In comparison, a heart transplant increases the lifespan of patients by almost twenty years. “Aeson Introduces a New Way to Treat End-Stage Heart Failure, Physiological Cardiac Replacement Therapy, Aimed to Provide Patients with a Significantly Improved Quality of Life“, believes Stéphane Piat. The artificial heart aims to allow patients to survive while waiting for a natural transplant, today 900 people are waiting for a transplant in France.
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