Objectives:
The PediaFlow® is a miniature, implantable, rotodynamic, fully magnetically levitated, continuous-flow pediatric ventricular assist device (VAD). The 4th generation PediaFlow® (PF4) was evaluated in vitro and in vivo to characterize performance and biocompatibility.
Methods:
Supported by two NHLBI contract initiatives to address the limited options available for pediatric patients with congenital and/or acquired cardiac disease, the PediaFlow® was developed with the intent to provide chronic cardiac support for infants as small as 3 kg. The University of Pittsburgh-led Consortium evaluated PF4 prototypes both in vitro and within a preclinical ovine model (n=11). The latter experiments led to multiple redesigns of the inflow cannula and outflow graft resulting in the implantable-design represented in the most recent implants (n=2).
Results:
With over a decade of extensive computational and experimental efforts spanning four device iterations, the AA battery-sized PF4 has an operating range of 0.5–1.5 L/min with minimal hemolysis in vitro and excellent hemocompatibility (e.g.: minimal hemolysis and platelet activation) in vivo. The pump and finalized accompanying implantable components demonstrated pre-clinical hemodynamics suitable for the intended pediatric application for up to 60 days.
Conclusions:
Designated a Humanitarian Use Device (HUD) for “mechanical circulatory support in neonates, infants, and toddlers weighing up to 20 kg as a bridge to transplant, a bridge to other therapeutic intervention such as surgery, or as a bridge to recovery” by the FDA, these initial results document the biocompatibility and potential of the PediaFlow® PF4 design to provide chronic pediatric cardiac support.