Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device

Abstract

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.

Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010–2021

“…(F) Diagram of Cleveland Clinic Pediatric TAH. (G) Diagram of double inlet–double outlet Fontan pump from Granegger et al Device photographs from Figure 4 are reprinted with permission from the following companies and/or individuals, whom the authors wish to acknowledge: Berlin Heart, Inc. (9391 Grogan’s Mill Road, Suite A‐6, The Woodlands, TX 77380); Abbott Cardiovascular (5050 Nathan Lane North, Plymouth, MN 55442; Dr. Kiyota Fukamachi and the Cleveland Clinic (9500 Euclid Avenue, Cleveland, OH 44195) 70 ; Salim Olia and PediaFlow (HeartWare International, 500 Old Connecticut Path, Framingham, MA 01701) 52 ; Windmill Cardiovascular Systems (7801 N Lamar Blvd, Suite E212, Austin, TX 78752); Dr. Marcus Granegger and the Medical University of Vienna (Universitätsring 1, 1010 Vienna, Austria) 79 …”

“…The VAD has not yet received device approval 51 . Meanwhile, the PediaFlow device (HeartWare International, Framingham, MA) (Figure 4C) continued independent development after the PumpKin program despite not achieving FDA approval; the most recently published fourth‐generation iteration of the device is a compact design (17 mm in diameter by 50 mm in length) which can provide support for infants as low as 3 kg and flows as low as 0.5 L/min 52 …”

Alternatives to PumpKIN: The ongoing development of ventricular assist devices for infants

“…2 Similar improvements in the management of adolescents have been achieved with the use of adult pumps in progressively smaller children. 3 The article by Olia and colleagues 4 in this issue of the Journal describes the ongoing effort to extend these improvements to the smallest children.…”

“…Olia and colleagues 4 have been developing a continuousflow ventricular assist device intended for intracorporeal insertion into infants as small as 3 kg. Although the article describes preliminary animal work, it is encouraging.…”

Overcoming bumps to build little pumps

“…4 One of these devices is the PediaFlow (LaunchPoint Technologies Inc, Goleta, Calif) infant ventricular assist device and is described in detail in this issue of The Journal of Thoracic and Cardiovascular Surgery by Olia and colleagues from the University of Pittsburgh. 5 This report describes the development and preclinical performance of their PediaFlow device. The most current iteration of the device, the PF4 (Launch-Point Technologies Inc), can be seen as a miniature counterpart to the most current adult device that has magnetic bearings.…”