PediaFlow(TM) VAD Consortium Receives $5.6 Million NIH Contract to Ready Device for Clinical Trials
LaunchPoint Technologies, Inc. and its fellow Consortium members have been awarded a $5.6 million contract from the National Institutes of Health (NIH) to pursue the continued development of the PediaFlowTM VAD, an implantable heart-assist device for infants and small children with congenital or acquired heart disease. The four-year program, known as 'Pumps for Kids, Infants, and Neonates (PumpKIN) Preclinical Program,' will enable the PediaFlow Consortium to complete preclinical testing and obtain FDA approval to begin clinical trials.
The PediaFlowTM VAD is one of four projects sponsored by the $23.6 million NIH National Heart, Lung, and Blood Institute (NHLBI) PumpKIN Preclinical Program. The PediaFlow Consortium, under the direction of Dr. Harvey Borovetz, Distinguished Professor and Chair of the Department of Bioengineering at the University of Pittsburgh, includes researchers and developers from the University of Pittsburgh; Children's Hospital of Pittsburgh; Carnegie Mellon University; World Heart Corporation (WorldHeart); and LaunchPoint Technologies, Inc. (LaunchPoint).
The PediaFlowTM VAD is a fully magnetically-levitated (maglev) blood pump, approximately the size of an AA battery. The pump design is an evolution of the award-winning maglev technology originally developed at LaunchPoint in collaboration with Dr. James Antaki and the University of Pittsburgh, and further refined during collaborations with WorldHeart on their LevacorTM VAD (currently in US bridge-to-transplant clinical trials). A recently completed five-year NIH contract allowed the Consortium to make significant progress in pump miniaturization and to successfully complete a multi-month in vivo implant in late 2009. The bearing-less blood pump is designed to offer excellent blood-compatibility with acceptably low energy consumption, and to ultimately provide up to six months of extended circulatory support for infants and children recovering from heart surgery or awaiting a heart transplant.
The three other PumpKIN awardees are Ension, Inc., Pittsburgh, PA; University of Maryland School of Medicine; and Jarvik Heart, Inc., New York, NY.
According to the NHLBI, nearly 1,800 infants die each year as a result of congenital heart defects and another 350 develop heart disease. Of those placed on the heart transplant list, approximately 60 infants and children under the age of 5 lose their lives each year while waiting for a donor heart.
"This research seeks to develop technologies to expand life-saving options for infants and children born with congenital heart defects or those who develop heart failure," noted Susan B. Shurin, M.D., pediatrician and Acting Director of the NHLBI. "Well-designed circulatory support devices are expected to substantially improve the outcomes of the infants and young children who need them as they seek to recover or wait to receive a heart transplant."