Artificial heart maker Carmat will begin sales of its devices from the second quarter of this year after a long-awaited European Commission approval.
The device aims to give patients with end-stage biventricular heart failure, a deadly condition where the heart is no longer able to pump blood adequately around the body, an alternative to hospital stays.
Carmat calls its device “the world’s most advanced total artificial heart project” although they are not the first company to create artificial hearts. US group Syncardia has been selling an artificial heart for nearly two decades.
“Syncardia is very important in the history of artificial hearts because they proved that it’s possible, and it works, to change a human heart for a device,” Carmat’s chief executive, Stéphane Piat, says. “But Syncardia’s is a very old technology and we are very far from what they are doing.”
“If you compare our device to what has been achieved so far with other solutions, we are much better and we have no complications,” he told Vantage.
Carmat’s device, to be marketed under the brand name Aeson, will be made available in Germany, possibly followed by France and other countries.
It is also launching a study in the United States this quarter with the hope of getting approval from the Food and Drug Administration for its device by 2024.