CARMAT, 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, 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.
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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 Since then, the MDD has been replaced by the Medical Device Regulation (MDR), which significantly strengthens the requirements to be met.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.
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.”
