The world’s most sophisticated total artificial hearts. Aeson, was created by CARMAT to offer a therapeutic option for those experiencing end-stage biventricular heart failure. CARMAT today announced that it has received the required regulatory approvals to resume commercial implant procedures.
DeKRA has given notified body approval of all the changes made by the Company in response to the quality problems that prompted it to voluntarily and temporarily suspend all Aeson implants at the end of 2021 after reviewing CARMAT filings. This authorization enables CARMAT to resume commercial Aeson artificial hearts implants in the European Union and other CE-certified nations.
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The DEKRA’s clearance permits us to resume implantation in a commercial context in Europe. Additionally, plans to resume clinical studies are moving along well; we will provide further details on this as they become available.