Overview

The HeartWare Ventricular Assist System has been designed to address many of the issues that have historically limited the clinical uptake of mechanical circulatory assist systems. At the core of the system is the HVAD^TM Pump, a miniaturized centrifugal pump which is designd to be implanted within the pericardial space and to eliminate the need for abdominal surgery.  The device has only one moving part and no mechanical bearings.    

HeartWare completed enrollment in a 50-patient international clinical trial in late 2008. The HeartWare Ventricular Assist System was awarded CE Mark approval in January 2009 and is now commercially available in Europe. 

In the United States, the System is the subject of an ongoing Bridge-to-Transplant clinical trial under which HeartWare enrolled 140 patients at 30 participating centers. Patient follow-up for that study is expected to conclude in August 2010, with subsequent PMA submission to the FDA.  HeartWare is also seeking to commence a Destination Therapy clinical trial in the United States.