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NHLBI funds preclinical tests on devices for infants and children with congenital heart defects
Date:2/4/2010

studies and other tests in artificial environments for the most promising devices in order to gain approval from the FDA to begin clinical testing.

Devices in the program will provide suitable circulatory support for newborns, older infants, and children less than 55 pounds who experience heart failure due to congenital and acquired cardiovascular disease. They are designed to supply adequate blood flow to prevent organ damage while minimizing the risk of blood vessel damage, infection, breakdown of red blood cells, excessive bleeding, brain damage, and dangerous blood clots. The devices are intended to support circulation in pediatric patients for one to six months, be sufficiently small and reasonably portable, and be able to be routinely positioned and functioning in less than one hour, among other specifications.

"Similar devices are used in adults," Shurin noted. "As an adult, your heart is normally about the size of your fist; devices for small children require radically different designs from adult devices to adapt to the differences in the size of the patients."

The program will test ventricular assist devices (VADs) and advanced extracorporeal membrane oxygenator (ECMO) devices. The VADs in the PumpKIN program are very small rotary pumps which are implanted to provide circulatory support for extended periods of use. They work by drawing blood from the heart and pumping it to the body. ECMO devices circulate and supply oxygen to the blood, and are commonly used for patients who need both heart and lung support. For ECMO devices, tubes connecting the patient to the device are placed directly into large blood vessels near the base of the neck. Blood is drawn from the right side of the heart, pumped through the oxygenator, and then returned to the body on the left side of the heart so the oxygen-rich blood can be delivered throughout the body.

The contractors will conduct all preclinical animal testing and analysis i
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Contact: NHLBI Communications Office
nhlbi_news@nhlbi.nih.gov
301-496-4236
NIH/National Heart, Lung and Blood Institute
Source:Eurekalert

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