Full clinical tests of the hearts are continuing but they have already been put into 15 people, and 11 of them survived at least six months after the operation. In each case the recipient was in the final stage of heart failure and would have been certain to die within weeks.
In Germany a network of 20 hospitals has approved the use of the heart and Carmat will be charging around €150,000 each.
Managing director Stéphane Piat said: “Faced with the shortage of heart transplants, we want to offer an alternative that, until now, has not existed.”
He said it was still better to have a heart transplant, where the expected lifespan after the operation is 20 years, but there are only 500 heart transplants carried out each year in France for a waiting list of 10,000 people.
If all goes to plan, approval to sell the heart in France will be given in 2023, after the completion of a further study, in which it will be placed in 52 patients. The French national authority for health (Haute Autorité de Santé) is contributing €13million to the research.
Mr Piat said the heart had taken 30 years of research and hundreds of millions of euros for the company to be able to reach this stage.
The Carmat heart is made up of three parts, the first being the actual heart and its cable. The heart has four biological valves, two ventral cavities separated by a flexible membrane – one for blood and the other for a hydraulic fluid – a pump system with two miniature pumps, an electronic control board, and a bag outside the heart containing reserve hydraulic fluid.
Added to that is an external belt kit weighing less than 5kg, which allows the patient to get out of bed and move around for at least four hours before the batteries need to be recharged.
The third part is the hospital machine which allows the medical teams to set up the heart when it is implanted and to monitor its performance and change parameters, if needed, afterwards.