The first implantation of the artificial heart of the French company Carmat took place in December 2013. Four trials followed. The goal was that at least half of the terminally ill patients survive at least 30 days thanks to this heart. Bet won, one of the participants even broke the record by living with this heart for 9 months! These first conclusive trials were then able to lead to the “pivot” clinical trial. The latter consists of the implantation of the heart in about twenty patients, younger and less severely affected than in the feasibility study. The objective was to then live 6 months with this prosthesis and the study should have ended in December 2017 in order to open up the commercialization of the Carmat heart.
A clinical trial which is exported, but which is lagging behind
However, this “pivot” trial was suspended for 6 months. Indeed, after the death of the first patient included in this new study following improper handling of the device’s batteries, the ANSM (the National Medicines Safety Agency) demanded new safety guarantees. Resumed in May, this clinical trial had taken place exclusively in France.
For the first time, the Carmat company has just successfully carried out the first transplant of its artificial heart. abroad. It was carried out in Kazakhstan, National Research Center for Cardiac Surgery, in Astana. The operation was carried out by the team of Dr Yuriy Pya, cardiac surgeon and director general of the center. The company nevertheless remains very secret about the date of the operation, the identity and the patient’s state of health. The ultimate goal is to be able to guarantee at least 5 years of additional life expectancy for patients considered to be terminally ill.
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