(AOF) – The medtech Carmat has obtained the necessary regulatory authorizations to resume the implantations of the Aeson artificial heart in the commercial context. Notified Body Dekra approved all changes made by Carmat, in response to quality issues that had led the company to voluntarily temporarily suspend all Aeson locations at the end of 2021. This approval allows Carmat to take over Aeson’s facilities on a commercial basis, in the European Union and in other countries recognizing CE marking.
Following this approval, Carmat intends to gradually resume its sales in Europe in the near future, in line with the reconstitution of its stocks of prostheses. The company will inform the market when it is able to resume clinical trials in France, Europe and the United States.
Stéphane Piat, Managing Director of Carmat, said: “Dekra’s approval allows us to resume Aeson implantations in the commercial framework in Europe, which is excellent news for both patients and our company. We We will reactivate implantations very soon in a progressive manner, depending on the reconstitution of our stock of implantable prostheses, and in order to allow appropriate follow-up of patients. We are also progressing well in the process of resuming clinical trials and will provide additional information to this topic when the time comes.”
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