The PediPump: A Versatile, Implantable Pediatric Ventricular Assist Device—Update IV

Abstract

Cleveland Clinic's PediPump (Cleveland, OH, USA) is a ventricular assist device designed for the support of pediatric patients. The PediPump is a mixed-flow ventricular assist device with a magnetically suspended impeller measuring 10.5 mm in diameter by 64.5 mm in length. Progress and achievements for the PediPump program are considered according to the development project's three primary objectives: Basic engineering: along with size reductions, substantial design improvements have been incorporated in each design iteration including the motor, magnetic bearings, axial touch points, and heat transfer path; Anatomic modeling and device fitting studies: Techniques based on computed tomography and magnetic resonance imaging have been developed to create three-dimensional anatomic-modeling and device-fitting tools to facilitate device implantation and to assist in preoperative planning. For in vivo testing, to date, six acute (6-h duration) and nine chronic (30-day target duration) implantations have been performed in sheep; the implantation of the PediPump appears to be relatively easy with excellent hemodynamic performance and minimal hemolysis during support. Cleveland Clinic's PediPump program supported by the National Heart, Lung and Blood Institute's Pediatric Circulatory Support Program has led to the development of a pediatric ventricular assist device that has satisfactory performance in preclinical evaluation and appears to be ready to support a program of clinical testing.

Challenges in pediatric mechanical circulatory support devices

“…9 As one of five awardees, we developed and tested the PediPump in small lambs. 10,11 This program was followed by the NHLBI's Pumps for Kids, Infants, and Neonates (PumpKIN) program in 2010, and the Jarvik 2015, a 40% larger version of the Infant Jarvik 2000, was developed under the PumpKIN program. 12 The US Food and Drug Administration granted conditional approval in October 2016 to conduct an IDE study of the Jarvik 2015.…”

Artificial Organs 2009: A Year in Review

“…Brian W. Duncan et al. (55) of the Cleveland Clinic, Cleveland, OH, USA reported on their VAD designed for the support of pediatric patients. The PediPump is a mixed‐flow VAD with a magnetically suspended impeller measuring 10.5 mm in diameter by 64.5 mm in length.…”

Extracorporeal Membrane Oxygenation Versus Counterpulsatile, Pulsatile, and Continuous Left Ventricular Unloading for Pediatric Mechanical Circulatory Support*

“…Five contracts were awarded to develop a family of mechanical systems to support infants and children with congenital or acquired heart disease. These included an apically-implantable mixed flow device[8], an apically-implantable continuous-flow device[9], an intravascular mixed flow device[10], a compact extracorporeal cardiopulmonary assist system[11], and an implantable pulsatile device[12]. Preclinical evaluation of four of these devices is underway as part of the NHLBI Pumps for Kids, Infants, and Neonates (PumpKINs) program[13] with clinical trials planned to begin in 2014.…”