August 25th 2021
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.”