FDA approves pump for heart-failure patients awaiting transplant

Hannah Blake

pharmaphorum

The US FDA has approved the HeartWare Ventricular Assist System, to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.

The HeartWare system is a left ventricular assist device (LVAD), which helps the heart’s left ventricle to pump oxygen-rich blood to the body. The mechanical pump is designed for use inside or outside the hospital.

“For patients awaiting a donor heart, the HeartWare System provides a new treatment option.”

Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.

While 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. The FDA’s approval was based on the life-saving benefits of the LVAD in the intended patient population, which outweighed the risks observed during clinical trials.

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