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.