Heart Failure (HF) is a devastating disease that affects more than 11 million people in the US and Europe, with an incidence of 1.1 million new cases per year. Furthermore, current growth rates predict a 25% increase in the incidence of HF by 2030.
According to the US National Institutes of Health (NIH), 100,000 patients could immediately benefit from a ventricular assist device (VAD) or total artificial heart (TAH), and the European market is similarly sized. Without intervention, patients with severe HF have a bleak outlook. For these patients, drug therapy is a limited, relatively ineffective option. Although a heart transplant would meet their needs, only 4000 donor hearts are available globally each year.
Implantation of a TAH is a treatment option for patients with end-stage HF who need support while on a heart transplant waiting list or who do not qualify for a transplant. Removal of the native ventricles allows the device to completely replace the function of the native heart.