Development of next generation digital flat panel catheterization system: design principles and validation methodology

Abstract

The design principles that drove the development of a new cardiovascular x-ray digital flat panel (DFP) detector system are presented, followed by assessments of imaging and dose performance achieved relative to other state of the art FPD systems. The new system (GE Innova 2100 IQ TM ) incorporates a new detector with substantially improved DQE at fluoroscopic (73%@1μR) and record (79%@114μR) doses, an x-ray tube with higher continuous fluoro power (3.2kW), a collimator with a wide range of copper spectral filtration (up to 0.9mm), and an improved automatic x-ray exposure management system. The performance of this new system was compared to that of the previous generation GE product (Innova 2000) and to state-of-the art cardiac digital x-ray flat panel systems from two other major manufacturers. Performance was assessed with the industry standard Cardiac X-ray NEMA/SCA&I phantom, and a new moving coronary artery stent (MCAS) phantom, designed to simulate cardiac clinical imaging conditions, composed of an anthropomorphic chest section with stents moving in a manner simulating normal coronary arteries. The NEMA/SCA&I phantom results showed the Innova 2100IQ to exceed or equal the Innova 2000 in all of the performance categories, while operating at 28% lower dose on average, and to exceed the other DFP systems in most of the performance categories. The MCAS phantom tests showed the Innova 2100IQ to be significantly better (p << 0.05) than the Innova 2000, and significantly better than the other DFP systems in most cases at comparable or lower doses, thereby verifying excellent performance against design goals.