FDA Approves Life-Saving Heart Pump
Published date : 22 November 2012
Article date : 22 November 2012
Reuters reports on FDA approval for a heart pump manufactured by HeartWare International Inc. The device is designed to support blood flow in patients with with failing hearts who are awaiting a transplant. They say that the left ventricular assist device (LVAD) can be implanted in the chest near to the heart and used inside or outside a hospital.
Apparently, the FDA said the life-saving benefits of the device outweighed risks observed during the clinical trial, such as infection and stroke. The heart pump is already sold in Europe.
The FDA approval was based on data from a study of 137 patients with advanced heart failure who received the HeartWare LVAD. The data was compared with outcomes from patients followed by a medical database who used other mechanically assisted circulatory support systems. The article says that this is the first time that the FDA has approved an LVAD using information from a database as a comparison.
Source: Susan Kelly, Reuters.com, 20 November 2012
Read the full article here.
