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According to the American Heart Association, 62 million Americans suffer from heart disease and approximately one million die each year. Heart failure, the number one cause of death in the United States, accounts for one death every 30 seconds. Approximately 4.5 million Americans have congestive heart failure (CHF) and nearly half a million new cases are reported every year. CHF is a chronic condition in which at least one chamber of the heart is not pumping well enough to meet the body's need. Heart failure presents an increasing public burden of morbidity and mortality even as the mortality from coronary artery disease and hypertension is decreasing. It is estimated that at least 40,000 of these patients are candidates for heart transplantation; however, only 2,200 donor hearts are made available each year. While effective pharmacologic therapies have improved outcomes for mild to moderate CHF, the need for mechanical circulatory support is well defined and growing. These mechanical devices are connected to the weak ventricle (usually the left ventricle) of the heart and assist the pumping action by forcing blood from the ventricle to the aorta. As such, the term left ventricular assist device (LVAD) is often used to describe these mechanical blood pumps.



Current use of mechanical circulatory cardiac devices is dominated by the indications of post-cardiotomy shock and bridging to transplantation. According to data published in the Journal of the American College of Cardiology, about 6,000 patients a year receive support devices after cardiac surgery, in the U.S. alone. Thoratec Corporation, a leading medical device company, estimates that the current U.S. market is approximately $150 Million per year. If reliable, fully implantable, and wearable devices were available, estimates Journal of Health Economics, at least 100,000 patients annually in the U.S. could benefit from this technology. The anticipated sale price of mechanical pumps, i.e., LVADs (and associate electronics) ranges from $40,000 to $80,000. Therefore, the projected LVAD market for congestive heart failure patients is $4 billion to $8 billion in the U.S. alone. The annual growth rate is estimated as 12% to 15% due to the new cases of congestive heart failures diagnosed each year.




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