The first implantation of the pioneering bioprosthetic artificial heart created by CARMAT has been made in the United States, it has been announced.
The Aeson artificial heart was designed to fulfil an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure.
Now, the heart – hailed as the world’s most advanced artificial total artificial heart – has been implanted, CARMAT has confirmed.
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 groundbreaking research, especially in cardiology and heart surgery.
It is the first US hospital to implant Aeson within the framework of the Early Feasibility Study. Three additional US centres 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 three patients after 60 days, before the enrolment of the next seven patients.
Dr Milano says: “We are pleased to be the first US centre 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, CEO of CARMAT, adds: “We are honoured that our device is implanted at Duke University Hospital, which is recognised 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 centres are now fully trained and ready to join our first US clinical study that will be instrumental to our development in the world’s largest medical device market.”