Advanced total artificial heart designer and developer Carmat has announced the first Aeson heart implantation in a patient suffering from a cardiac tumour.
The patient who underwent the implant had a tumour that had invaded the cardiac mass, causing rhythmic and restricted cardiopathy that was not responsive to conventional medical care.
The only possible course of treatment could be total surgical removal of the heart. In this context, the Aeson artificial heart has been implanted for the first time globally.
Carmat said that the implantation was carried out at the Marie-Lannelongue Hospital in Plessis-Robinson located in the western suburbs of Paris, France.
It was conducted by the teams of cardiac surgeon Julien Guihaire and thoracic surgeon Elie Fadel, as part of the EFICAS clinical study.
The study aims to collect additional data on the Aeson artificial heart’s efficacy and safety, as well as medico-economic data to support the prosthesis value proposition.
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Eight cardiology centres in France are now involved in the trial.
So far, the first cohort enrolment of ten patients has been finalised for the study, which is scheduled for completion in 2025.
In a joint statement, Guihaire and Fadel said: “We are delighted to have been able to provide a solution to this patient in a very difficult situation, for whom there was no other alternative than a total heart replacement with Aeson.
“This first-in-man implant performed in our hospital is a continuation of the commitment to the Carmat project by our teams since the beginning of 2010, including in particular the performance of numerous implant simulations in the Marie-Lannelongue Hospital research laboratory. Aeson offers real hope for patients with invasive cardiac tumours whose treatment options and survival are currently extremely limited.”
Recently, Carmat announced plans to open a new production facility in Bois-d’Arcy, France.