Pump for Heart Failure Patients approved by FDA

Heart with EKG beat - BSN

(Best Syndication News) - The U.S. Food and Drug Administration (FDA) approved the HeartWare Ventricular Assist System. The device helps pump blood and is to be used for end-stage heart failure patients that are waiting for a heart transplant.

The left ventricular assist device (LVAD) is used to improve the heart’s left ventricle ability to pump oxygen-rich blood to the body. With the HeartWare system, there is an implanted pump along with an external driver and power supply. The patient receiving the HeartWare device will be able to use it inside and outside of the hospital.

This device is different from other LVADs because it does not require the components to be put in the abdomen. A smaller person could benefit from the HeartWare because they might not be able to take an abdomen implant; this product may suit them better.

In order to gain FDA approval, HeartWare LVAD conducted a clinical study called the ADVANCE trial. The trial involved 137 advanced heart failure patients who used the HeartWare System. The researchers measured HeartWare outcomes and compared them to similar patients followed by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). HeartWare LVAD patients had similar survival outcomes compared to INTERMACS patients.

The key adverse events were similar too, but there were serious adverse events, such as infection and stroke, associated with the HeartWare LVAD. The stroke risk associated with the HeartWare LVAD is something that doctors will need to discuss with the patients before using the device.

HeartWare Inc. of Framingham, Massachusetts, manufactures the HeartWare Ventricular Assist System.

By: Marsha Quinn
Health Reporter

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