Carmat aims to meet a major public health challenge related to cardiovascular diseases, namely heart failure, the leading cause of death in the western world. More specifically, Carmat aims to provide a lasting solution for the treatment of terminal heart failure, a disease for which there are very few effective options today, the main one being heart transplants.
Heart Failure occurs when the heart can no longer carry out its essential function as a “blood pump” to provide a sufficient cardiac output to satisfy the metabolic needs of the organism. It primarily affects the left chamber of the heart, then the right chamber leading to biventricular heart failure. At this stage, vital organs such as the brain, liver and kidneys do not receive enough nutrients and oxygen to function properly. The main symptoms of the disease include fatigue, shortness of breath (even at rest), and fluid retention.
Heart failure is a global pandemic affecting at least 26 million people and is increasing in prevalence (1). Despite significant advances in therapies and prevention, approximately 5% of this population have terminal heart failure, described as endstage heart failure, refractory to current medical treatment (2, 3).
As heart failure is a progressive disease, the prognosis is poor: less than 50% survival five years after diagnosis (4,5).
Heart transplantation has been the gold standard therapy; however, this therapy is constrained by the paucity of donors, which limits the number of transplants to about 5,500 patients per year (6). This gap between supply and demand prompted the development of mechanical circulatory support (MCS) systems.
Carmat aims to provide a long-term solution to treat end-stage biventricular heart failure, rated as Class IV under the NYHA system(7), for which a heart transplant is still the only truly effective alternative treatment.
(1): Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Cardiac Failure Review. 2017;03(01):7–11.
(2): Benjamin EJ, et al. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019;139(10):e56-e528.
(3): Ammar KA, et al. Prevalence and prognostic significance of heart failure stages: application of the American College of Cardiology/American Heart Association heart failure staging criteria in the community. Circulation. 2007;115(12):1563-70.
(4) : Stehlik J. et al. The Registry of the International Society for Heart and Lung Transplantation: 29th Official Adult Heart Transplant Report—2012 J Heart Lung Transplant October 2012 Volume 31, Issue 10, Pages 1052–1064
(5) : Miller L. W. Is Left Ventricular Assist Device Therapy Underutilized in the Treatment of Heart Failure? Circulation 2011;123;1552-1558
(6): ISHLT Annual registry Paper, Journal of heart and lung transplantation Volume 39, Issue 10, P997-1002, October 01,2020, Secular changes in organ donor profiles and impact on heart and lung transplantation
(7)The New York Heart Association (NYHA)
Aeson® is composed of 3 parts:
The implanted prosthesis consisting of the following components:
External equipment: It provides the mobility and autonomy needed to lead a near-normal life. It weighs 4 kg and includes a controller and two battery pockets providing an autonomy of approximately 4 hours.
The hospital care console: The medical team uses the hospital care console (HCC) to operate the prosthesis during implantation and track/monitor how the device is functioning.
Aeson® is an active implantable medical device intended to replace the ventricles of the native heart in patients suffering from advanced heart failure. The device is electro-hydraulically driven with a shape close to that of a human heart.
Once the Aeson® is connected, it duplicates the action of a normal heart, providing mechanical circulatory support and restoring normal blood flow through the body.
Aeson® is an active implantable device, commercially available in Europe ONLY, CARMAT SA, CE0344. The Aeson® TAH is intended to replace ventricles. It is indicated as a bridge to transplant in patients suffering from end-stage biventricular heart failure (INTERMACS classes 1-4) who are not amenable to maximal medical therapy or LVAD and are likely to undergo heart transplant in the 180 days following device implantation. The decision to implant and the surgical procedure must be taken by Healthcare professionals trained by the manufacturer.
In the USA, Aeson® is currently exclusively available within the framework of clinical trials.