CARMAT announces a software enhancement which significantly improves the safety profile of Aeson®

• In compliance with regulations, the implementation of this modification gives rise to the publication of a “field safety notice”.
• Its roll-out will begin over the next few days.

Paris, December 28, 2023 – 5:45 pm (CET)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), today announced a software enhancement which significantly improves the safety profile of its Aeson® artificial heart.

The prosthesis software will now be able to detect on a real time basis, signals of possible Aeson® malfunctions. The software will then immediately adapt the control of the prosthesis so that its performance is not affected, and the patient’s support is not impacted.

These changes, developed and tested by CARMAT’s research teams, will first be deployed on all hearts currently implanted in patients, as part of a software update for which a field safety notice is published[1]. It will then be embedded into the Aeson® production process, after getting the appropriate regulatory approvals.

Stéphane Piat, Chief Executive Officer of CARMAT, declares: “In all industries, electronic components are potentially subject to failure, because perfection of their manufacturing is almost impossible to achieve. It was important to be able to manage such risks in the case of our device, and I’m therefore very proud of the feat achieved by our software engineers: from now on, for many of the potential malfunctions linked to the prosthesis’s electronic components, Aeson® software will automatically “correct” these faults by adapting the prosthesis’s performance in an appropriate manner, so that the patient’s support remains unaffected. For me, this is a major and immediate step forward for all the patients who benefit and will benefit from our therapy; but also in the long term, when it comes to obtaining the destination therapy indication for Aeson®, as this improvement significantly strengthens the safety profile and therefore the potential durability of the prosthesis.”

[1] In France, publication is made on the ANSM health authority website.

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