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