October 25th 2022
DEKRA has provided notified body approval of all changes implemented by CARMAT
Paris, October 25, 2022 – 7 am CEST
CARMAT (FR0010907956, ALCAR), the designer and developer of Aeson®, the world’s most advanced total artificial heart, designed to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced today that it has been granted the necessary regulatory approvals to resume implants in a commercial setting.
After review of CARMAT filings, DEKRA has provided notified body approval of all the changes implemented by the Company in response to the quality issues that led it to voluntarily and temporarily suspend all Aeson® implants at the end of 2021. This approval allows CARMAT to resume implants of its Aeson® artificial heart in a commercial setting, within the European Union and other countries that recognize CE Marking.
Following this approval, CARMAT intends to resume sales in Europe in the near future at a gradual pace in line with the rebuilding of the prostheses inventory.
CARMAT will provide additional update when it is in a position to resume clinical trials in France, Europe and the United States.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “DEKRA’s approval allows us to resume Aeson® implants within a commercial setting in Europe, which is excellent news both for patients and for our Company. We will be resuming implants very soon and moving forward at a measured pace as we continue building our inventory of implantable prostheses, and ensure all patients are suitably monitored. We are also making good progress on plans to resume clinical trials and we will be providing additional updates on this in due course”.