March 6th 2023
The publication highlights the effectiveness of the device based on the combination of hemocompatibility and autoregulation
Paris, March 6, 2023 – 7:00 am CET
CARMAT (FR0010907956, ALCAR), the designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, today announced that the first U.S. clinical experience with Aeson® has been published in the Annals of Thoracic Surgery Short Reports, the journal of the U.S. Society of Thoracic Surgeons.
The article, entitled The First Autoregulated Total Artificial Heart Implant in the United States, describes the Aeson®’s implant performed at Duke University Hospital in the summer of 2021 within the framework of the Early Feasibility Study (EFS).
The authors report that Aeson® total artificial heart (TAH) provides right- and left-sided heart replacement for a patient suffering from biventricular failure with notable improvements over prior-generation circulatory support devices. These include enhanced hemocompatibility and autoregulation enabling increased output in response to higher filling pressures.
The authors conclude that the first U.S. experience demonstrates the effectiveness of the Aeson® TAH while preventing stroke and bleeding complications. The patient was successfully bridged to transplant as a donor organ became available after 5 months of support on the device, and has made a full recovery.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are gratified that our device provided such an efficient support to the first U.S. patient. Aeson®’s hemocompatibility translates in an unparalleled safety profile with absence of bleeding complications or stroke, which are the main drawbacks of conventional mechanical circulatory support devices. Furthermore, the blood flow autoregulation, which is unique to Aeson®, facilitates physical activity and patient readiness for a successful cardiac transplant. These distinctive features once again confirm our belief that Aeson® will become the therapy of choice for advanced biventricular heart failure. We continue to work with the FDA to resume the EFS, a key step towards obtaining authorization to market Aeson® in the U.S.”