ORLANDO, Fla. – The U.S. Food and Drug Administration Tuesday approved a new Ventricular Assist System to support heart function and blood flow in patients awaiting heart transplants.
The device is called HeartWare. It is designed to support heart function and blood flow in patients with end-stage heart failure.
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According to the FDA, an LVAD is a mechanical pump used to support heart function and blood flow in people who have weakened hearts.
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.
The HeartWare System is small enough to be implanted in the chest near the heart, allowing for implantation in smaller adults or patients unable to have an implant in the abdomen. The life-saving benefits of the LVAD in the intended patient population outweigh the risks observed during the clinical trial.