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FDA NEWS RELEASE

For Immediate Release: Dec. 16, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves mechanical cardiac assist device for children with heart failure

The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.

The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

“This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children,” said Susan Cummins, M.D., M.P.H, chief pediatric medical officer in the FDA’s Center 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.”

The device consists of one or two external pneumatic (driven by air) blood pumps, multiple tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit.

Heart failure in children is much less common than in adults. Heart transplantation offers effective relief from symptoms. However, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting the use of heart transplantation in children and prolonging the waiting period until transplant can occur. In infants, the median waiting time for a donor heart is 119 days. Overall a reported 12-17 percent of children and 23 percent of infants die while on the wait list for a heart transplant. 

In the primary U.S. study group of 48 patients, the use of the device was found to improve survival to transplant in patients when compared with the use of extracorporeal membrane oxygenation (ECMO) which is the current standard of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Pediatric System. 

The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. This designation is for medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States annually. The device was approved under a Humanitarian Device Exemption (HDE), a type of marketing application that is similar to a premarket approval application in that the level of safety required for approval is the same. Rather than having to show a reasonable assurance of effectiveness, devices submitted under the HDE marketing route need to prove that the probable benefit from use of the device outweighs the probable risk of illness or injury from its use to obtain the FDA’s approval.

The FDA approval of an HDE authorizes an applicant to market the device subject to certain use restrictions. After the passing of the Pediatric Medical Device Safety and Improvement Act of 2007, HUDs intended and labeled for use in a pediatric population are permitted to be marketed for profit. 

The FDA’s Orphan Products Grant Program supported the U.S. clinical trials for the EXCOR Pediatric System with grants of $400,000 per year for three years.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
 

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