The French company Carmat announced on Friday “voluntarily temporarily suspending” the implantations of its Aeson artificial heart. She mentions “the occurrence of a quality problem which affected some of her prostheses”, without giving further details.
This heart aims to offer a therapeutic alternative to patients suffering from terminal biventricular heart failure.
Last July, Carmat announced that it had sold the first copy of its artificial heart, marketed under the Aeson brand. In mid-September, she indicated that she had made other “sales” in Europe, indicating that six patient implantations had been carried out in Germany and Italy. A press release dated September 21 mentioned an establishment in the United States, then on November 15 another in the Netherlands.
Carmat indicates that the quality problem which led to the suspension of the implantations of his artificial heart “will be investigated in accordance with the protocol provided for this purpose”. “Following this investigation, Carmat will communicate, as soon as it is able to do so, on the resumption of its establishments”, continues the medtech in its press release.
Common events in the life cycle of medical devices
This suspension “will allow us to calmly analyze the problem which has arisen and to draw conclusions”, indicates Stéphane Piat, general manager of the company, considering that “the quality problems constitute usual events in the cycle of life of medical devices, especially in the phases of production ramp-up “.
In December 2020, Carmat obtained CE marking in Europe, which gave it the green light for the marketing of its artificial heart in Europe.