Carmat has announced the resumption of commercial implants of its Aeson total artificial heart.
Carmat announced on 25 October that the DEKRA notified body had approved all the changes implemented on Aeson, allowing the company to resume commercial implants in the European Union (EU) and other regions that recognise the CE mark.
In view of this, a first commercial implant of Aeson was performed in a German hospital last week, the company noted in a press release. Implants will continue to resume at a gradual pace in line with the rebuilding of its inventory of implantable prostheses, Carmat added.
Stéphane Piat, chief executive officer of Carmat, said: “The resumption of implants was eagerly awaited by many physicians, and we are delighted that European patients are able to benefit from our therapy again. In accordance with our roadmap, we continue to rebuild our inventory of prostheses, paying particular attention to quality control, in order to be in a position to gradually meet demand from medical centres, both in a commercial setting and within the framework of our clinical trials.”