Wednesday, February 10, 2010

NHLBI Funds Tests for Devices

The National Heart, Lung, and Blood Institute (NHLBI) has awarded four contracts totaling $23.6 million to begin preclinical testing of devices to help children born with congenital heart defects or that may develop heart failure. The program is called Pumps for Kids, Infants, and Neonates (PumpKIN).

The program’s goal is to complete the needed animal studies and other tests in artificial environments so that the most promising devices will be able to gain approval from the FDA to begin clinical testing. NHLBI’s funding will support the next phase of the PumpKIN program by enabling further testing and further development of these devices.

The contractors that received the awards are Harvey S. Borovetz, Phd., University of Pittsburgh, Mark Gartner, PhD., Ension, Inc., Pittsburgh, PA, Bartley P. Griffith, M.D., University of Maryland, Baltimore, and Robert Jarvik, M.D., Jarvik Heart Inc., New York, N.Y.

To initially address the problem, NHLBI launched the Pediatric Circulatory Support Program in 2004 by funding the development of five novel circulatory support devices for infants and young children with congenital and acquired cardiovascular disease.

The devices supported in that program provide suitable circulatory support for newborns, older infants, and children who weighed less than 55 pounds and experienced heart failure due to congenital and acquired cardiovascular disease. The devices that were developed were 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.

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