December 19, 2011
FDA Approves First Heart Pump For Children Awaiting Transplant
The U.S. Food and Drug Administration (FDA) said on Friday that it has approved the first heart pump for children with heart failure, giving a new treatment option for patients who are too small to receive adult implants.
The ventricular assist device is made by Germany-based Berlin Heart, and is the first heart pump approved to help children survive as they await a heart transplant. The device does the work of a normal heart in children with congenital or other cardiovascular defects, allowing them to be kept alive with their organs functioning as they wait for a donor heart.
The ventricular assist device is similar to the one used by former Vice President Dick Cheney, but scaled down for children.
Canada and Europe have already approved the device, named Excor, said Berlin Heart in a statement.
“This is a landmark event for children suffering from terminal heart failure,” said Charles Fraser Jr., head of congenital heart surgery at Texas Children´s Hospital and professor of surgery and pediatrics at Baylor College of Medicine in Houston. "The medical community is now able to offer this lifesaving device to support desperate children who would not otherwise survive while awaiting a heart transplant,” he told Bloomberg News.
The Berlin Heart device was tested in 48 U.S. children beginning in November 2007 in the first-ever pediatric trial of a mechanical heart pump. An FDA advisory panel recommended approval in July.
The FDA's approval of the ventricular assist device means hospitals can now stock the device in a range of sizes -- from walnut-size pumps for babies to orange-sized pumps for teens.
"I will sleep better knowing there's a Berlin Heart sitting here in the Cleveland Clinic," said pediatric cardiologist Dr. Gerald Boyle of the Cleveland Clinic. "In the middle of the night, if we have a device here we can support the patient immediately,” he told ABC News.
However, the Berlin Heart device is only a temporary fix, since children who receive it will ultimately need a heart transplant.
"For families with a child who needs a heart transplant -- and there are enough of those -- we can say, 'We'll try to get a heart, but while we wait we have a plan,'" said Boyle.
"This device gives us confidence that the number of patients who die waiting will decline dramatically."
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