The specific aim is to complete the development of a reliable and biocompatible pediatric circulatory support device, known as the PediaFlow, to provide needed circulatory support for up to six months in the high-risk population of children with heart failure between 3 kg and 15 kg. The device is intended to be fully implantable with a single, small caliber percutaneous lead, will include a smart sensor-based controller and specially-designed cannulae sets, and will limit anticoagulation to anti-platelet medications. The device will be implanted in an animal model during the final two years of the program and begin formal reliability studies in the fifth year.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 V AD patients, cardiovascular physiology and clinical ventricular assistance for adult and pediatric patients.During the final two years of the RFP Program, 12 in vivo implants are planned using hermetically sealed PVAD systems. Four of the final in vivo studies will utilize perigestational lambs as a model of the anatomy/physiology of our proposed patient population. Three biventricular support implant trials are also planned along with four extended (six month) LV implants. We believe that our PVAD system will be ready to begin formal reliability qualification at the end of the 5-year RFP program.
