Carmat has received MDR CE marking for its Aeson artificial heart, allowing its commercialisation for patients with end-stage biventricular heart failure in the European Union and other regions that recognise the certification.
According to the company, Aeson is intended as a bridge to transplantation for patients awaiting a donor heart. Carmat claims the device is designed to reduce complications typically associated with mechanical circulatory support by closely replicating the natural heart’s blood flow and pulsatility.
The company said this MDR CE marking replaces its previous CE certificate granted in December 2020 under the former Medical Device Directive (MDD). Carmat stated that the new certification also includes expanded clinical data, which it says support the device’s safety and performance profile.
The company plans to resume commercial implants in selected European centres by September 2025, after pausing implants in late 2022 to resolve manufacturing process issues. Carmat also announced it will continue patient enrolment in its EFICAS clinical study in France, aiming to support broader reimbursement and gather further real-world data.
Carmat said the MDR CE mark is valid until July 2029. The company believes this milestone positions it to address what it describes as a critical unmet need for patients with advanced biventricular heart failure who are not immediately eligible for transplantation.
