The U.S. Food and Drug Administration today approved the
HeartWare Ventricular Assist System, a left ventricular assist
device (LVAD), to support heart function and blood flow in
patients with end-stage heart failure who are awaiting a heart
transplant. An LVAD is a mechanical pump used to support heart
function and blood flow in people who have weakened hearts.
LVADs are the most common type of ventricular assist devices,
and they help the heart's left ventricle pump oxygen-rich blood
to the body. The HeartWare System includes an implantable pump
with an external driver and power source. It is designed for use
inside or outside the hospital. "For patients awaiting a donor
heart, the HeartWare System provides a new treatment option,"
said Christy Foreman, director of the Office of Device
Evaluation in FDA's Center for Devices and Radiological Health.
Other available LVADs require components to be placed in the
abdomen. The HeartWare System is small enough to be implanted in
the chest near the heart, allowing