PI Harvey Borovetz
Title Pumps for Kids, Infants and Neonates (PumpKIN) Preclinical
Program: The PediaFlow™ Pediatric VAD
Co-Investigators William Wagner, Marina Kameneva, Steve Webber, and Peter Wearden
Description For the past five years our consortium, consisting of the University of Pittsburgh and the Children’s Hospital of Pittsburgh, Carnegie Mellon University, LaunchPoint Technologies and WorldHeart Inc., has undertaken an ambitious program to develop a pediatric blood pump, motivated by the critical need to treat infants and toddlers with congenital and acquired heart diseases. We have relied on first principles to develop, de-novo, a miniature blood pump specifically intended for this population. The first phase of this program has produced the PediaFlow™ PF3, believed to be the world’s smallest magnetically levitated (maglev) blood pump with the following outstanding features:
Unparalleled biocompatibility, due to our maglev technology, streamlined single-flowpath design, and computer-optimization design process.
Exceptionally small, due to our supercritical (above resonance frequency) rotordynamic technology.
Valveless turbodynamic design with one moving part to minimize size.
Optimized computationally using first principles of bioengineering and physics.
Lightweight controller and battery designed for reliability and failsafe operation.
Human factors design specifically for pediatric operation.
Cannulation designed to facilitate removal for bridge to recovery.
With a flow rate range between 0.3 -1.5 LPM and a footprint approximating a AA cell battery, the clinical PediaFlow VAD will provide circulatory support for neonates, infants, and children less than 20 kg who experience cardiac failure and circulatory collapse due to congenital and acquired cardiovascular disease. Our consortium is uniquely poised to carry this forward to clinical use, fulfilling the needs of the PumpKIN program. The individual and collective strengths of our individual organizations and our unique and close collaborations over decades have resulted in innovative implantable blood pumps introduced to clinical use and trials following regulatory approvals.
The overall objectives of our response to the PumpKIN RFP are to finalize device development and conduct pre-clinical qualification testing necessary to apply for an IDE for a US clinical trial within 2.5 years. Specifically:
I. Finalize the current PediaFlow (PF3) pediatric VAD, leading to the clinical PediaFlow VAD design;
II. Conduct all necessary pre-clinical in-vitro and in-vivo testing with the clinical PediaFlow VAD design;
III. Submit an application and obtain IDE approval for the PediaFlow VAD;
IV. Collaborate with the PumpKIN Data Coordinating Center (DCC) and the other PumpKIN pre-clinical contractors to develop the clinical protocol and monitoring procedures which will be used in the PumpKIN program clinical study; and
V. Provide regulatory, manufacturing, training, and technical support for the PediaFlow VAD while the clinical study is underway.
Successful completion of these aims will produce a pediatric ventricular assist device that will provide new opportunities for pediatric cardiac therapy and especially for the very smallest patients. Our very successful work for the past five years under the NHLBI Pediatric Circulatory Support Program (N01-HV-48192) serves as the basis for our current PumpKIN RFP application.
Source National Heart, Lung and Blood Institute, NIH
Term 4 years