CARMAT has announced the second centre implanting its bioprosthetic artificial heart, Aeson, in the USA within the framework of the Early Feasibility Study (EFS).
The implant procedure was performed by a team led by Mark S Slaughter, professor and chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville (UofL) and UofL physician at Jewish Hospital, Louisville, USA. Jewish Hospital is the second US hospital to implant Aeson within the framework of the EFS. Three additional US centres are fully trained and are currently screening patients for the study.
In accordance with the study protocol approved by the US Food and Drug Administration (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 three patients after 60 days, before the enrollment of the next seven patients.
Slaughter, principal investigator of the study, stated: “We are pleased to be part of the first US centres to investigate this new artificial heart technology. This clinical study will help us determine whether the device’s distinguishing features such as haemocompatibility 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 honoured that our device is implanted at UofL Health – Jewish Hospital and University of Louisville, which is recognised throughout the USA 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.”