Coronary artery disease is the number one killer of both men and women in the United States today. Three million myocardial infarctions are recorded annually in the U.S., with an accompanying mortality rate of approximately 15%. The annual costs for screening of patients at risk for cardiac diseases using nuclear medicine imaging procedures alone are greater than 500 million US dollars. A reduction in mortality is expected with improved diagnostic imaging procedures for cardiac diseases. However, it is difficult to develop and evaluate improved cardiac imaging methods and protocols without a realistic heart phantom. The long term goal of this project are the development of a Dynamic Heart Phantom (DHP) system that consists of both the left and right ventricles for use in clinical protocol evaluation, quality assurance and training. Phase II specific aims are to: (1) continue analysis of the size and shape of the ventricles; (2) develop technologies to model normal and ischemic myocardium and cost-effective manufacturing methods for the DHP; (3) development and testing of the control and monitoring system for the DHP; and (4) evaluate the imaging characteristics and performance of the DHP using multimodality clinical imaging equipment at three independent clinical sites.
We expect to manufacture a DHP system from commercially available components and materials using customized processing equipment. The system will be easy to operate and robust with a goal of Mean Time Between Failure (MTBF) of 125 hours. The targeted sales price range is $7,500 to $15,000 per system. Projected first year sales are 250 systems with an expected total sales of 5,000 systems over the expected 10 year life of the product.