Clinical NeedSmartHeart Left Ventricular Assist Device (LVAD)SmartHeart Total Artificial Heart (TAH)

Products and Technology
Clinical Need:
Approximately 23.0 million patients suffer from heart failure worldwide with 2.0 million new cases diagnosed each year. The U.S. accounts for 5.0 million of these patients with 550,000 annual new cases. Approximately 10.0% of heart failure patients are in Class IV, suffering from the most severe symptoms. Only 2,000 - 2,500 patients in the U.S. receive a heart transplant annually while more than 25,000 die while waiting for a donor heart. The National Institutes of Health estimates 100,000 U.S. patients per year could benefit from left ventricular assist device (LVAD) technology. This population is extremely underserved with LVADs being implanted in only about 3000 of these patients annually. Up to 40.0% of LVAD recipients develop right heart failure and require right ventricular assist device (RVAD) or total artificial heart (TAH) support. Clinical need for a total artificial heart is estimated at 5,000 - 10,000 annually.

While several devices targeting this population are either on the market or in clinical trials, significant complications and limitations demand further device improvements.

A key feature of Cleveland Heart's technology platform is the ability to miniaturize the pump mechanism without an expectation that clinical performance of the system will be compromised. Based on this platform, the key focus of Cleveland Heart's Advanced Product Development team is to develop a family of further miniaturized devices, implantable by progressively less invasive surgery. We believe that by reducing the invasiveness of the procedure, we have the potential to dramatically expand the use of mechanical circulatory support systems for the treatment of heart failure.

Left Ventricular Assist deveice (LVAD) and Total Artificial Heart