October 23rd 2023
Paris, October 23, 2023 – 7:00 am (CEST)
CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), announces that it has presented its progress on the EFICAS clinical trial at the 36th “Journées de La Pitié” national conference on heart and lung transplantation and circulatory assistance, organized by the cardiology institute of the Pitié Salpêtrière hospital from October 18 to 20, 2023 in Paris.
Prof. Christian Latrémouille, Director of Surgical Affairs at CARMAT, provided an update on the latest progress of this large-scale study at a session dedicated to innovations: “Seven Aeson® implants have been performed as part of the study since its initiation in several of the French centers involved. The pace of study enrollment is accelerating, with 4 implants performed over the last 4 weeks. This ramp-up is the result of growing experience in patient selection and attest to the steep learning curve of the surgical procedure. Post-operative patient recovery is increasingly satisfactory, which gives us great confidence in Aeson®’s performance and the success of the study, anticipated to be completed in 2025. I would like to thank all the participating teams for their commitment and look forward to seeing additional centers join us in our efforts to offer as many patients as possible an effective alternative to heart transplant.”
EFICAS is a prospective study designed to include 52 patients eligible for transplants, currently enrolled by a network of 6 French cardiology centers. It will enable CARMAT to gather additional data on the efficacy and safety of its 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. The primary objective of the study is 180-day post-implantation survival without disabling stroke, or successful heart transplant within 180 days of implantation.
Pr. Lebreton of Pitié Salpêtrière Hospital (AP-HP), Paris, says: “We are delighted to have implanted a first patient with the Aeson® total artificial heart as part of the EFICAS clinical study. The patient is recovering very quickly, and most of his symptoms of advanced heart failure have already disappeared.”
Pr. Obadia of Hôpital Louis Pradel (Hospices Civils de Lyon), principal investigator of the EFICAS study, comments: “With our second Aeson® implant within a month, our learning curve is rapid, and we remain impressed with the device’s performance. The CARMAT team provides excellent support to the hospital teams, before, during and after each implant.”
Pr. Vincentelli of the Lille Regional University Hospital (CHRU), says: “The Aeson® heart is an absolute necessity in the therapeutic arsenal against end-stage heart failure. This total artificial heart has enabled us to safely prepare and wait for heart transplants in young patients who have no longer responded to conventional treatment.”
CARMAT teams also attended the 7th “Journée” VAD Meeting, organized by the French-speaking coordination for the development of cardiac assistance (COFDAC), on October 19, 2023. This was an opportunity to demonstrate the Aeson® device to VAD coordinators in France, who play a key role in the management of patients on circulatory assistance.