The market potential for total artificial hearts (TAHs) is estimated to be over 200,000 units per year in Europe and the US. Credit: Have a nice day Photo/Shutterstock

Paris-based artificial organ developer CARMAT has announced it will open a new production facility in Bois-d’Arcy, France.

This will be the second facility opened by the company which will be in the same vicinity as their first operations site.

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The new facility has been reviewed by the notified body DEKRA who approved it to produce the Aeson total artificial heart, a therapeutic alternative for people with end-stage biventricular heart failure also known as congestive heart failure.

The market potential for total artificial hearts (TAHs) is estimated to be over 200,000 units per year in Europe and the US. While the global market for cardiovascular surgery devices is estimated to reach $1,300.9 million by 2025.

This expansion will support CARMART’s production capabilities to reach a production capacity of 500 hearts per year as soon as 2024.

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Stéphane Piat, CEO of CARMAT, said: “The opening of our new production facility is a major achievement, and I would like to thank all the teams who have worked relentlessly to ensure that it is delivered on schedule before the end of 2023. Today, with the historical “BDA1” facility and this new “BDA2″ facility, we have a high-performance manufacturing tool that is certified to produce up to 500 hearts per year from 2024. In line with our strategic plan, we will further develop our industrial set-up over the next few years, to reach an annual production capacity of 1,000 Aeson hearts by 2027.”

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At the start of 2023 the company submitted its Aeson artificial heart within the framework of the EFICAS clinical study in France. In March 2023 it had its first US clinical experience which was published in the Annals of Thoracic Surgery Short Reports, the journal of the US Society of Thoracic Surgeons.