Magnetic levitation motor for pediatric cardiac and cardiopulmonary therapies - Phase II

Abstract
This Phase II STTR application represents the main research and development effort for an innovative, low
cost, magnetic levitation motor specifically designed for neonatal and pediatric extracorporeal cardiac and
cardiopulmonary therapies. Our Phase I efforts demonstrated feasibility of a novel magnetic levitation motor
enabling contact-free blood pump impeller operation. Contact-free operation eliminates critical areas of wear
as well as reduces heat generation that can contribute to hemolysis and thrombosis. The extracorporeal
pediatric market is currently served by a single magnetically levitated blood pump (Abbott PediMag). As with
many neonatal and pediatric medical products, the PediMag is a scaled-down version of an adult blood pump
that was designed for post-cardiotomy support (Abbott CentriMag). While PediMag has been used
successfully in a range of post-cardiotomy support applications, broader usage is limited by several factors
including lack of ancillary componentry designed specifically for the pump system (e.g., pediatric blood
oxygenator and heat exchanger), complex control algorithms, and a high disposable cost (approximately
$8000 per disposable PediMag pump head). To address these shortcomings, we developed an innovative and
simplified magnetic levitation motor that eliminates the costly rare earth magnetic elements from the disposable
blood-contacting component to the reusable motor stator. Our magnetic levitation motor design also permits
simplified control algorithms for improved robustness and reduced power requirements. The levitation motor
uses the same impeller and pump housing geometry as currently integrated in Ension’s pediatric
cardiopulmonary assist system’s (pCAS) pump-oxygenator and replaces the mechanical bearings, rotating
shaft, and blood contacting seal. Our strategy to retain the current pCAS pump geometry both lowers overall
development costs and permits the use of existing comprehensive in vitro and in vivo test data for performance
comparisons. In Phase I, we completed two acute and one 3-day chronic animal study that demonstrated
Phase I feasibility and confirmed a Phase II effort is warranted. Goals in Phase II include motor and controller
optimization, expansion of a risk-based design history file (DHF) consistent with FDA’s Quality System
Regulation (QSR), and conduct of a range of performance testing to establish safety and reliability. Phase III
commercialization activities will include a transfer to manufacturing and verification and validation testing to
support a regulatory filing to support clinical trials in pediatric patients with cardiac and/or cardiopulmonary
dysfunction.Narrative
Many pediatric medical products are scaled-down versions of adult products. For example, the only
magnetically levitated blood pump available for pediatric circulatory support is a scaled-down version of its
adult counterpart. This project intends to develop an improved magnetically levitated blood pump designed
specifically for the pediatric cardiac and cardiopulmonary life support in neonatal and pediatric patient
populations.