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FDA Approves Cardiac Device for Children Awaiting Transplant

Human heart and arteries (Yale School of Medicine/Wikimedia Commons)

(Yale School of Medicine/Wikimedia Commons)

The U.S. Food and Drug Administration (FDA) on Friday approved the Excor Pediatric System, a device to support children with heart failure until a donor for a heart transplant can be found. The device is made by Berlin Heart GmbH in Germany and The Woodlands, Texas.

The Excor Pediatric System is an external heart pump for children suffering from heart failure. It consists of one or two external air-driven blood pumps, tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit.

The Excor device is made in different sizes for children ranging in age from infants to teenagers. It is designed as a temporary support system for children awaiting a heart transplant until a donor can be found. The company says the Excor system can also be used as an alternative to a hear transplant in some patients.

While heart failure among children is less common than adults, the number of donor hearts is also much smaller. As a result, heart transplants are also less common for children and waiting periods are often longer. FDA says in infants, the median waiting time for a donor heart is 119 days, and anywhere from 12 to 17 percent of children — including 23 percent of infants — die while on the waiting list for a heart transplant.

The Excor Pediatric System was tested in a four-year clinical trial in the U.S. The results showed the device to improve survival to transplant in patients when compared to extracorporeal membrane oxygenation (ECMO), considered the current standard of care, although not FDA approved. Stroke is a risk from use of the Excor device.

FDA says the system was designated a Humanitarian Use Device  because it treats a condition affecting fewer than 4,000 individuals a year in the U.S., and approved under its Humanitarian Device Exemption (HDE). Rather than having to show a reasonable assurance of effectiveness, devices submitted under HDE 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 FDA approval.

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