The French company Carmat announced on Thursday that it had completed its investigations around the "quality problem" which had pushed it to voluntarily suspend the implantations of its artificial heart in early December.
"This investigation (...) made it possible to identify the origin of the quality problem, and to determine the changes required to prevent it from happening again," the company said in a press release, without specifying the nature of the failure. .
"Take over the sites as soon as possible"
Several weeks of discussions around the investigation could elapse before a resumption of establishments by Carmat.
The company plans to make a new update in January.
“We are going to work diligently with all regulatory stakeholders in order to resume implantations as soon as possible, while keeping quality and patient safety as our top priorities,” commented Carmat CEO Stéphane Piat.
Last July, the company announced that it had sold the first copy of its artificial heart, marketed under the Aeson brand, which offers a therapeutic alternative to patients suffering from terminal biventricular heart failure.
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