CARMAT receives FDA conditional approval to initiate the second cohort of the EFS study in the United States

The implant was performed at UofL Health – Jewish Hospital by University of Louisville physicians within the framework of the U.S. Early Feasibility Study

Paris, August 25, 2021 – 7:00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the second center implanting its bioprosthetic artificial heart, Aeson®, in the United States within the framework of the Early Feasibility Study (EFS).

The implant procedure was performed by a team led by Dr. Mark S. Slaughter, Professor and Chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville and UofL Physician at Jewish Hospital, Louisville, Kentucky. UofL Health and the University of Louisville are known for ground-breaking cardiovascular innovation research, especially in circulatory support technologies. Jewish Hospital is the second U.S. hospital to implant Aeson® within the framework of the EFS. Three additional U.S. centers are fully trained and are currently screening patients for the study.

In accordance with the study protocol approved by the FDA, 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.

Mark S. Slaughter, MD, heart surgeon at UofL Health – Jewish Hospital and University of Louisville, and principal investigator of the study, stated: “We are pleased to be part of the first U.S. centers to investigate this new artificial heart technology. This clinical study will help us determine whether the device’s distinguishing features such as hemocompatibility and blood flow autoregulation are beneficial to critically ill patients suffering from biventricular heart failure who currently have very limited treatment options.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We are honored that our device is implanted at UofL Health – Jewish Hospital and University of Louisville, which is recognized throughout the United States for its quality of care and cardiovascular research. I would like to congratulate the teams at the hospital, as well as our technical and medical staff, on this exceptional milestone for both patients and our company.”

The implant was performed at Hannover Medical School

Paris, July 26, 2021 – 6:00 pm CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the first implant of its Aeson® bioprosthetic artificial heart in Germany.

This new implant of the Aeson® artificial heart was performed by Prof. Jan D. Schmitto and his interdisciplinary Heart Team of the Department of Cardiothoracic and Transplant Surgery (Director: Prof. Axel Haverich) at Hannover Medical School (Medizinische Hochschule Hannover – MHH), in Germany. The MHH Hospital is a maximum care hospital with a nationwide catchment area, recognized for its quality research in several domains such as transplantation and regenerative medicine, infection and immunology, biomedical engineering and implants.              

Prof. Jan D. Schmitto, Director of the Mechanical Circulatory Support and Cardiac Transplantation Program at Hannover Medical School, declared: “The implant of the first CARMAT TAH in Germany represents another milestone in the field of Mechanical Circulatory Support Devices. The extremely ill patient suffered from long-lasting congenital heart disease and was finally fulminantly decompensated. He was treated by extracorporeal membrane oxygenation (ECMO) therapy for many days before he received a left ventricular assist device (LVAD) plus aortic valve replacement (AVR) and a temporary right ventricular assist device (RVAD) a week ago. Based on persistent right heart failure which made the RVAD not able to be weaned, there were no other treatment options left than Aeson® in this specific situation. Therefore, we asked the CARMAT team to join our forces for this ultima ratio use in order to face that critical situation of our patient. Unfortunately, because of its terminally ill status and the extremely fragile clinical profile, the patient passed away in the postoperative course. However, we observed that Aeson® has been able to directly intraoperatively stabilize the hemodynamic situation of the patient and has also been able to cope with the high pulmonary arterial pressures. Overall, we have been impressed by the promising performance of the device and we are looking forward to include it in our portfolio to save many lives in the future.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We supported Prof. Schmitto’s team in Hannover last Friday for the treatment of a young patient suffering from end-stage biventricular heart failure due to Congenital Heart Disease. Because of the lack of treatment options for this severe heart failing patient and taking into account the challenging management of his severe Pulmonary Arterial Hypertension (PAH), Aeson® has been identified as the last possible solution. Despite challenging hemodynamic conditions, our device was able to deal with this very high level of PAH. This finding could open new opportunities in terms of indication of use for congenital heart diseases. We continue screening patients in Hannover as well as in other centers in Germany which have already been trained in the use of Aeson®.”