PARIS, FRANCE: CARMAT announced the first implantation of its bioprosthetic artificial heart, Aeson, in the United States within the framework of the Early Feasibility Study (EFS).
CARMAT is 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.
The implant procedure was performed by a team led by Dr. Jacob N. Schroder and Dr. Carmelo A. Milano, heart surgeons at Duke University Hospital, in Durham (North Carolina). Duke University Hospital is rated as one of the best in the United States for its outstanding care and ground-breaking research, especially in cardiology and heart surgery. It is the first 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.
Carmelo A. Milano, MD, heart surgeon at Duke University Hospital, and principal investigator of the study, stated: “We are pleased to be the first U.S. center to investigate a new therapeutic alternative for critically ill patients suffering from end-stage biventricular heart failure. This clinical study will help us determine whether the device’s properties — including hemocompatibility, pulsatility, autoregulation and silent operation — are beneficial to patients who currently have very few options.”
Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We are honored that our device is implanted at Duke University Hospital, which is recognized throughout the United States for its quality of care and 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. I am also very pleased that, despite the procedures hardened by the Covid-19 situation, three other centers are now fully trained and ready to join our first U.S. clinical study that will be instrumental to our development in the world’s largest medical device market.”