? In the United States, approximately 4,000 pediatric patients per year require a ventricular assist device (VAD) due to idiopathic cardiomyopathy or congenital heart defects. Despite this tremendous need, there is currently no specially designed VAD commercially available in the US for pediatric use. The ultimate goal of this project is to develop a percutaneous VAD (pVAD) for pediatric patients ranging from 3.5 kg to 50 kg based on our existing adult pVAD system. The proposed system is intended to deliver support of up to 50% of the patient's normal cardiac output. Due to the wide range of patient sizes, and consequent wide variety of support levels needed, the served patient population has been divided into six segments based on patient's body size. For each patient segment, cannula of proper size will be developed for device placement. A pediatric pump will be designed based on the existing adult blood pump. Controller will be redesigned for pediatric application. Feasibility prototypes will be manufactured and tested under simulated clinical use conditions to demonstrate that the proposed design can deliver the required support for each patient segment. Hemolysis testing will be conducted to demonstrate that the proposed design does not cause excessive blood damage. Phase II study includes optimization of the proposed design and animal testing. After successful completion of Phase I and II, clinical trial and commercialization of the proposed device will follow. The proposed system is simple and low cost. Because it is inserted percutaneously, cardiac assistance can be provided quickly and with minimum invasiveness, subsequently minimizing potential complications and promoting quicker recovery. Successful commercialization of this device will provide a new tool for use in pediatric cardiology and surgery, and will help save children's lives. ? ?
