French-listed CARMAT [Euronext Paris: ALCAR], the designer and developer of the world’s most advanced total artificial heart, which is aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure, has completed the first implantation of its proprietary Aeson heart in a patient suffering from a cardiac tumour.
CARMAT said that the patient implanted was suffering from a tumour invading the heart mass, responsible for rhythmic and restrictive cardiopathy, which eluded standard medical treatment. Only complete surgical removal of the heart could be considered as a hope of treatment. It is in this context that the Aeson total artificial heart was implanted, the first time in the world in this type of indication has been carried out.
CARMAT is a French medtech that designs, manufactures and markets the Aeson artificial heart. CARMAT’s ambition is to make Aeson the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts.
The world’s first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson could save, every year, the lives of thousands of patients waiting for a heart transplant.
Aeson is used as a bridge to transplant
The device offers patients quality of life and mobility thanks to its ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking.
Aeson is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States.
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The implant was carried out at the Marie-Lannelongue Hospital in Plessis-Robinson (in the western suburbs of Paris) by the teams of Professor Julien Guihaire, cardiac surgeon, and Professor Elie Fadel, thoracic surgeon.
Professors Julien Guihaire and Elie Fadel explained further: “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.”
The surgeons said Aeson offers “real hope” for patients with invasive cardiac tumors whose treatment options and survival are currently extremely limited.
CARMAT efficacy and safety study
The implant was performed as part of CARMAT’s EFICAS study, which aims to gather additional data on the efficacy and safety of its Aeson artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France.
Eight French cardiology centers are now involved in the EFICAS study, which will include a total of 52 patients. To date, enrolment of the first cohort of 10 patients has been finalized, and the study is on track for completion in 2025.
Stéphane Piat, Chief Executive Officer of CARMAT, added: “I would like to thank the teams at the Marie-Lannelongue Hospital, a long-standing partner, for giving new hope to a patient suffering from major comorbidities. We are delighted with this world first for CARMAT, which demonstrates the ability of Aeson® to address increasingly complex clinical cases.”
