SBIR-STTR Award

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.

Thesaurus Terms:
auxiliary heart prosthesis, biomedical equipment development, cardiac output, circulatory assist, pediatrics congenital heart disorder, heart dimension /size, hemolysis, hypertrophic myocardiopathy bioengineering /biomedical engineering, medical implant science

Remarkable progress has been made over the last decade on ventricular assist devices for adult heart failure patients. Thousands of patients' lives have been saved each year. Unfortunately, similar devices are not yet available in the US for pediatric heart patients. Development of such devices has been impeded by the fact that the pediatric market size is too small to attract interest from medical device companies. This Phase II study is a part of a National Institutes of Health effort of encouraging industry to develop such devices for an underserved but high-benefit population - pediatric heart patients. The goal of this project is to further develop a pediatric percutaneous ventricular assist device (pVAD) based on the existing adult TandemHeart(tm) pVAD System developed and currently marketed by our company, CardiacAssist, Inc. In the Phase I study, feasibility of such a device for pediatric application was successfully demonstrated on the bench top. Phase II study will focus on development of complete clinical prototypes and animal testing. Specifically, a spectrum of different sized cannulae will be developed to serve pediatric patients of all ages, from neonates (> 2 kg) to young adults. State of the art computational fluid dynamic and fluid visualization techniques will be used to design a safer and more effective blood pump for this pediatric application to reduce the levels of hemolysis. Safety and functionality of the developed system will be demonstrated in animal models. Upon successful completion of Phase II, CardiacAssist will undertake the final design and commercialization phase to introduce this device into the market. The proposed pediatric pVAD system is the only one in the field that can be placed percutaneously and serve pediatric patients of all sizes. Because it is inserted percutaneously, cardiac assistance can be provided quickly and less invasively, minimizing potential complications and promoting quicker patient recovery. Successful commercialization of this device will bring a unique tool to pediatric cardiologists and surgeons for their use in saving children's lives.

Thesaurus Terms:
auxiliary heart prosthesis, biomedical equipment development, circulatory assist, clinical biomedical equipment, pediatrics biomedical equipment safety, catheterization, evaluation /testing, hemodynamics, medically underserved population bioengineering /biomedical engineering, swine