First ever human implant of fully artificial heart announced
pharmafile | July 15, 2021 | News story | |Â Â cardiovascularÂ
CARMAT has announced that the first ever human implantation of their fully artificial heart, which was designed as a therapeutic alternative to people suffering from end-stage biventricular heart failure.
The bioprosthetic artificial heart, Aeson, was implanted 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 the first hospital the implant an Aeson within the framework of the Early Feasibility Study (EFS) in the US. There are three other centres that are currently working on screening patients for the procedure 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.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “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.”
The Aeson is comprised of an implantable bioprosthesis and a portable external power supply system to which it is continuously connected, it has a unique self-regulation system and a pulsatile nature.
The EC has backed CARMAT’s work, which has been granted the largest subsidy ever given to an SME by Bpifrance, a total of €33 million. In a release, CARMAT said the company aims to eventually provide a response to a major public health issue associated with heart disease, the world’s leading cause of death: chronic and acute heart failure.
Carmelo Milano said: “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.”
Kat Jenkins
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