The National Institutes of Health (NIH), World Heart Inc., and the University of Pittsburgh recently awarded LaunchPoint Technologies an additional $490K to continue the development of a next-generation PediaFlowTM Pediatric Ventricular Assist Device (VAD), the PF3. According to Dave Paden, LaunchPoint Technologies' VP of Mechanical Engineering and PediaFlow Project Manager, the additional funds reflect a growing confidence in the projected ability of the PF3 design to meet key clinical performance criteria.
The PediaFlow PF3, the simplest and smallest blood pump of its kind, is being developed to provide up to 6 months of extended circulatory support for infants and children under the age of 2 years (< 15 kg body weight). It is the only implantable pediatric rotary blood pump with a fully magnetically levitated rotor. This technology enables the pump to operate without contacting moving surfaces, seals, or fluid film bearings, significantly reducing the potential for blood cell damage.
The five-year, $4.49M PediaFlow program is one of only five projects funded in 2004 by the NIH National Heart, Lung, and Blood Institute (NHLBI) to design a cardiac/cardiopulmonary support device for pediatric applications. The PediaFlow Pediatric VAD is being developed by a research consortium comprised of the University of Pittsburgh, Carnegie-Mellon University, the Children’s Hospital of Pittsburgh, WorldHeart Inc., and LaunchPoint Technologies Inc. The PediaFlow consortium has recently applied for follow-on NIH funding to finalize the clinical PF3 design, conduct all verification and validation testing, set up manufacturing, and submit an IDE application to the FDA. Award decisions will be made by NIH in late August or early September.