Pediatric Ventricular Assist Devices

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Laboratory for Innovation and Optimization of Medical Devices
CIRCULATORY SUPPORT FOR INFANTS AND SMALL CHILDREN
Harvey S. Borovetz, PhD – Principal Investigator
UNIVERSITY OF PITTSBURGH
James F. Antaki, PhD - Project Director, CARNEGIE MELLON UNIVERSITY
Brad E. Paden, LaunchPoint, LLC
Pratap Khanwilkar, MedQuest Products, Inc.
The very limited options available to treat ventricular failure in patients with congenital and acquired heart diseases have
motivated the development of this RFP application. Our proposal represents a consortium consisting of the University of
Pittsburgh (UOP), Children’s Hospital of Pittsburgh (CHP), MedQuest™ and Magnetic Moments, LLC with the overall aim of
developing a highly reliable, biocompatible ventricular assist device for chronic support (6 months) of the unique and high-risk
population of children between 3 kg and 15 kg (patients from birth to two years of age). The innovative PVAD we will develop
is based on a miniature centrifugal flow pump featuring magnetic levitation, to assure minimal blood trauma and risk of
thrombosis.
Clinical design requirements for our pediatric ventricular assist device (PVAD) include:

fully implantable with a single, small caliber
percutaneous lead crossing the skin for energy and
data transmission;

suitable for up to six (6) months continuous support

anticoagulation requirement limited to anti-platelet
medications (with the option for Coumadin if clinically
indicated);

a “smart” sensor-based hemodynamic controller will be
included to continuously monitor cardiac status for
potential “bridge-to-recovery” applications. Our
controller will also continuously monitor the
performance of the PVAD and produce a flow pulse of
programmable amplitude and frequency;

specially-designed pediatric cannulae sets suitable for
both RV and LV support will be included.
A multi-disciplinary program is proposed which capitalizes on our years of industrial experience in developing mechanical
circulatory support devices, plus our collective expertise in cardiovascular bioengineering (e.g., computational analyses, flow
visualization, control theory, electromagnetics), and related sciences (biocompatibility, immunology, and biorheology) as
applied to VAD patients, cardiovascular physiology and clinical ventricular assistance for adult and pediatric patients.
We believe that our PVAD system will be ready to begin formal reliability qualification in 2009.
REV. 1.14.04
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