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US approves heart pump for kids

2011-12-18 09:12

Washington - The US Food and Drug Administration has approved a first mechanical cardiac assist device for children that can help keep patients alive as they await a transplant.

The EXCOR Paediatric System, made by German company Berlin Heart, can be sized to fit young people from newborns to teenagers.

"This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," said Susan Cummins, chief paediatric medical officer in the FDA's Centre for Devices and Radiological Health.

"Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart," she added in a statement on Friday.

The device was tested on a group of 48 US patients, and was found to improve survival rates for transplant patients compared with the use of extra-corporeal membrane oxygenation, the current standard of care, though not FDA approved.

As a whole, a reported 12-17% of children and 23% of infants die while they await heart transplants, according to the FDA.