Science

Artificial heart: Carmat “temporarily” suspends its establishments due to a “quality problem” – Sciences et Avenir

The French company Carmat announced this Friday “voluntarily and temporarily” the implantations of its Aeson artificial heart, after “the appearance of a quality problem that had affected some of its prostheses,” according to a press release.

This heart aims to offer a therapeutic alternative to patients suffering from end-stage 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 he indicated that he had made other “sales” in Europe, stating that six patient implants had been performed in Germany and Italy. A press release dated September 21 reported on one establishment in the United States, then on November 15 another in the Netherlands.

“After the occurrence of a quality problem that affected some of its prostheses, the company has made the decision to temporarily suspend, as a preventive measure, the implantations of its Aeson artificial heart”, indicates the press release published this Friday, without more details. .

“This event will be investigated in accordance with the protocol provided for this purpose. After this investigation, Carmat will communicate, as soon as it can, about the resumption of its establishments ”, continues the medtech.

This suspension “will allow us to calmly analyze the problem and draw conclusions”, says Stéphane Piat, CEO of the company quoted in the press release, considering that “quality problems are common occurrences. In the life cycle of devices doctors, especially in the acceleration phases of production. “

“Aeson’s quality and patient safety remain our top priority,” says Piat.

In December 2020, Carmat obtained the CE marking in Europe, which gave it the green light for the commercialization of its artificial heart in Europe.

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