There are approximately 5.3 million patients with heart failure (HF) in the US and this is rapidly growing by 660,000 each year. 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. 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.
 Cardiac Assist: Pumping the Heart Failure Market. MTI Nov, 2008
 Heidenreich PA, et al.(2011), ‘Forecasting the Future of Cardiovascular Disease in the United States: A Policy Statement From the American Heart Association’, Circulation. 2011