July 28th 2025
Paris, July 28, 2025 – 6:00 pm CEST
CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces that it has obtained CE marking under Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation – MDR), which replaces the former Medical Device Directive (MDD 93/42/EEC). This new certification covers the bridge to transplant (BTT) indication and applies to the Aeson® system as a Class III active implantable medical device.
MDR CE marking certifies Aeson®’s compliance with the most stringent European regulatory requirements
The MDR CE marking certifies Aeson®’s compliance with the latest European standards and requirements relating to patient safety, clinical performance, risk management, and post-market surveillance. It was granted following a rigorous and comprehensive review conducted by the notified body DEKRA.
In December 2020, Aeson® had obtained CE marking in the bridge to transplant indication, under the Medical Device Directive (MDD), which was in force at the time. Since then, the MDD has been replaced by the Medical Device Regulation (MDR), which significantly strengthens the requirements to be met. Class III medical devices such as Aeson®, which were CE marked under the MDD before May 2021, have until May 2027 to obtain MDR CE marking. Failing to do so would mean the device could no longer be marketed in the European Union after this date.
The MDR certification confirms and reinforces Aeson®’s recognition by health authorities.
A strengthened regulatory foundation to support European and international growth and future extension of Aeson®’s indications
Obtaining MDR CE marking, well ahead of the transition deadline, means that from a regulatory perspective, Aeson® can continue to be marketed in the European Union[1] beyond May 2027.
This certification also reinforces the Company’s position in view of a future expansion of Aeson®’s indications, notably towards destination therapy[2] (DT), as well as in its U.S. market access strategy, currently targeted for 2028.
As a reminder, Aeson® is currently the only CE-marked implantable total artificial heart.
Readers are also reminded that the Company is currently placed in receivership procedure (opened on July 1, 2025) and is therefore facing a very high risk of default, including in the very short term.
Stéphane Piat, Chief Executive Officer of CARMAT, concludes: “I would like to congratulate our teams on obtaining MDR CE marking for the Aeson® artificial heart, following an extremely demanding process that mobilized many of our employees for months. I would like to underline that Aeson® is, and currently remains, the only implantable artificial heart being CE-marked and thus marketed in Europe. In the particular context in which CARMAT currently finds itself, this MDR certification is a further independent recognition of Aeson®’s quality and performance by health authorities. From a regulatory perspective, we have thus already secured the right to continue marketing Aeson® across Europe even beyond 2027, for patients suffering from advanced heart failure. I hope we will successfully get out of the receivership procedure we are currently in, so that patients can effectively continue benefitting from our therapy going forward. Finally, I would like to add that the “MDR” CE marking is also extremely important in view of getting access to the U.S. market, and future extension of Aeson®’s indications towards permanent patient support.”
[1] and in other countries which recognize CE marking.
[2] Destination therapy (or DT): in this indication, Aeson® would be implanted permanently without subsequent heart transplantation.