There are approximately 5.3 million patients with heart failure (HF) in the US and this is rapidly growing by 660,000 each year[1]. Similar numbers are found between Europe and Australia (See Figure 1). According to the American Heart Association, deaths in the USA attributed to heart failure increased by 28% in the period from 1994 to 2004. This rate is approximately set to continue at until 2030[2]. A number of factors are driving this increase, including an ageing population and the fact that HF will develop from untreated hypertension and myocardial infarction.

The prognosis of HF is bleak: drugs can become ineffective in late stage HF and some 70-80% of patients die within eight years of diagnosis. In the USA alone, 100,000 people are in the end stages of the disease (severe HF) and many would die while waiting for a heart transplant without additional circulatory support. Unfortunately, each year there are only 2000 donors in the USA and a further 2000 worldwide. Those lucky enough to be placed on a donor list may receive a VAD/TAH device to bridge them to transplant, but there are many more patients that require longer term support, including those who are ineligible for a transplant.

VADs and TAHs address this large and underserved patient population, regardless of the patients transplant status, and open up a huge unmet market for new devices.