CARMAT announces the first human implant of its total artificial heart in the US – implant was performed at Duke University Hospital, one of the US’s largest cardiology centres.
CARMAT has announced the first implantation of its bioprosthetic artificial heart, Aeson®, in the US within the framework of the Early Feasibility Study (EFS).
Longevity.Technology: CARMAT is the designer and developer of what it claims is the world’s most advanced total artificial heart; the company is aiming to fulfil an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure. Affecting, both sides of the heart, biventricular heart failure can cause symptoms of both right-sided and left-sided heart failure, and limits both lifespan and quality of life.
Heart disease is the world’s leading cause of death; being able to replace failing hearts could revolutionise lifespan and massively reduce the healthcare burden. Perhaps it could even propel us on our journey towards longevity escape velocity, the point where life expectancy will continually be extended longer than the time that is passing.
Aeson is composed of an implantable bioprosthesis and a portable external power supply system, to which it is continuously connected.
By pursuing the development of its total artificial heart, CARMAT aims to eventually provide a response to the major public health issue associated with chronic and acute heart failure and overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end-stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.
Aeson is the result of combining two types of expertise: the medical expertise of Professor Carpentier, known for inventing Carpentier-Edwards® heart valves, which are the most used in the world, and the technological expertise of Airbus Group, a world aerospace leader.
Physiologic heart replacement therapy
Due to its highly-biocompatible materials, self-regulation system and its pulsatile nature, the CARMAT total artificial heart could, assuming a successful clinical development, potentially save the lives of thousands of patients each year with no risk of rejection and with an enhanced quality of life.
Aeson has the backing of the European Commission; CARMAT has been granted the largest subsidy ever given to an SME by Bpifrance: a total of €33 million.
The implant procedure was performed by a team led by Dr Jacob Schroder and Dr Carmelo Milano, heart surgeons at Duke University Hospital, in Durham (North Carolina). Duke University Hospital has a solid cardiology and heart surgery research track record, and it is the first 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 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, who is also principal investigator of the study, said: “We are encouraged that our patient is doing so well after the procedure Monday … As we evaluate this device, we are both excited and hopeful that patients who otherwise have few to no options could have a lifeline [1].”
Stéphane Piat, Chief Executive Officer of CARMAT, added: “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 US clinical study that will be instrumental to our development in the world’s largest medical device market [1].”
