McGowan Institute for Regenerative Medicine
faculty member Peter Wearden, MD, PhD, Assistant Professor of Cardiothoracic Surgery at Children’s Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC), is the principal investigator of the University of Pittsburgh (Pitt) subcontract on the National Institute of Health (NIH) award issued to Levitronix to perform both preclinical and clinical assessment of a pediatric ventricular assist device (VAD) called the UltraMag pediatric VAD. Other collaborators include McGowan Institute faculty member Harvey Borovetz, PhD, Deputy Director William Wagner, PhD, and faculty member Marina Kameneva, PhD, as well as UPMC’s Timothy Maul, PhD, Victor Morell, MD, Steven Webber, MD, Diana Shellmer, MD, and Lisa Abraham, MD.
The objective of this research plan is to transition the development of the UltraMag ventricular assist system (VAS), which is designed to support neonates and small children, from the preclinical to the clinical trial phase. The work will culminate in a single center, prospective, nonrandomized, open-label, clinical trial. The 2001 report of the National Heart, Lung, and Blood Institute-sponsored Task Force on Research in Pediatric Cardiovascular Disease identified the pressing need for novel systems to support children with severely compromised cardiac disorders. The pediatric VAD under development by Levitronix and its development partners, the Texas Heart Institute and Pitt, is intended to fulfill the need for acute to chronic mechanical circulatory life support for up to 6 months in infants and small children. The goal will be to create a viable clinical product for infants and small children, based on the core magnetically levitated technology developed by Levitronix. Uniquely, this small centrifugal pump has no seals, bearings, or other movable parts that are traditionally associated with thrombus formation or mechanical failure.
In Phase I of the project, the team demonstrated the soundness of this technology for the pediatric application through a series of in vitro and in vivo experiments. In Phase II of the project, they optimized the pump design to accommodate the hemodynamic conditions typical for the pediatric patient, and demonstrated effective hemodynamic performance and biocompatibility in a series of in vivo implants simulating typical clinical conditions. The specific aims of this award include:
1. Demonstrate device endurance and biocompatibility in a juvenile ovine model to confirm readiness for clinical trials providing support up to 180 days. Physiological performance and biocompatibility of the blood pump, control systems, and cannulae will be assessed.
2. Conduct “preliminary clinical safety and probable benefit” trial for up to 180 days of the proposed system in 8 children (ranging from neonate to children weighing up to 40 kg) with decompensated congestive cardiomyopathy.
In addition, Harvey Borovetz, PhD (professor and chair in the Department of Bioengineering at the Pitt, a professor of Chemical and Petroleum Engineering, the Robert L. Hardesty Professor in the Department of Surgery, and the Deputy Director of Artificial Organs and Medical Devices within the McGowan Institute) received his third year funding from NIH for the Small Business Innovation Research Phase II project with Levitronix. This project is titled “Development of a Magnetically Levitated, Bearingless Pediatric Pump.” Dr. Borovetz’s co-investigators from the McGowan Institute include Marina Kameneva, PhD (Research Professor of Surgery in the University of Pittsburgh School of Medicine, Professor of Bioengineering, Pitt, and Director of the Artificial Blood Program at the McGowan Institute), William Wagner, PhD (Professor of Surgery, Bioengineering and Chemical Engineering at Pitt and the Director of Thrombosis Research for the Artificial Heart and Lung Program), and Peter Wearden, MD, PhD, as well as Victor Morell, MD, and Steven Webber, MD, of Children’s Hospital of Pittsburgh of UPMC. The objective of this work is to develop the PediVAS pump, and specifically to transition the development of a VAS designed to support neonates and small children from animal testing into a single center clinical trial.
Illustration: Levitronix and University of Pittsburgh.
Dr. Peter Wearden
Dr. Harvey Borovetz
Dr. William Wagner
Dr. Marina Kameneva