HeartWare Device Receives FDA Approval

The U.S. Food and Drug Administration has approved the HeartWare Ventricular Assist System.

The U.S. Food and Drug Administration has approved the HeartWare Ventricular Assist System, which is a device designed to help last stage heart failure patients who are awaiting a transplant.

Produced by HeartWare Inc., of Framingham, Mass, the device also called the left ventricular assist device (LVAD), will help the left ventricle of the patient’s weakened heart to pump blood into the body.

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The FDA said that the approval of the device was granted based on the results of a clinical study of 137 advanced heart failure patients.

The release added that the HeartWare device can be implanted as a single unit near the heart, but cautioned that the possibility of serious adverse reactions need to be taken into consideration before opting for this therapy.

Source-Medindia

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