Heart failure is a major cause of death throughout the world, and is associated with a high rate of morbidity and a lower quality of life than that of patients suffering from any other chronic disease. More than 10 million people suffer from heart failure worldwide. In the US alone, approximately 5 million people suffer from heart failure with more than 500,000 new diagnoses each year. Approximately 10% of heart failure patients, approximately 1 million, are at the end stage of the condition; these patients are considered Class IV heart failure patients per the New York Heart Association guidelines. HeartWare® estimates that each year approximately 100,000 Class IV patients worldwide might benefit from a left ventricular assist device (LVAD), such as the HeartWare® Ventricular Assist Device (HVADTM). The market for LVADs is increasing enormously each year, at a compound annual growth rate of 29.6% for 2010-2015, details in Table 1.
LVADS are used for two primary purposes when treating heart failure patients: bridge-to-transplant therapy (BTT) and destination therapy (DT). BTT refers to the temporary use of an LVAD while awaiting transplantation, whereas DT refers to the permanent or quasi-permanent use of an LVAD. While BTT patients account for the vast majority of the currently treated population, DT is the long-term goal and accounts for the majority of the prospective market. As such, HeartWare®'s primary emphasis is on DT; however, regulatory approval for BTT is an important interim step.
It is estimated that the market for heart failure patients worldwide who do not qualify for transplantation and would require destination therapy is as large 100,000 new patients annually. The ev...
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...s based upon the same principles as the MVAD™ but marketed towards pediatrics.
In addition to improving ventricular assist pumps, HeartWare® is also looking to improve its electronic products. It is currently working towards designing a prototype for an implanted controller, through the means of a Transcutaneous Energy Transfer System (TETS). 17 The goal is to successfully implant a battery and controller pack in the patient to eliminate connecting the pump to external electronics. The implanted TETS pack would be recharged via induction across the skin. 17 The TETS platform would eliminate the need for the external driveline, and consequently reduce the risk of infection caused by the driveline. These products in development aim to treat more heart failure patients while also providing more comfort and convenience to those who currently use a HeartWare® pump.
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