Technology | July 24, 2012

GE’s FREEdom Edition CT System Receives FDA Clearance

System introduced the world’s first cardiac spectral computed tomography scanner

July 24, 2012 — GE Healthcare announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its new cardiac imaging platform, the Discovery CT750 HD FREEdom Edition. Addressing the main challenges of cardiac imaging – coronary motion, calcium blooming, plaque composition and accurate myocardial perfusion – the FREEdom Edition is designed to provide a new level of cardiac CT (computed tomography) performance and to help physicians better serve patients.

Based on exclusive FREEdom technologies (Fast Registered Energies and ECG), the Discovery CT750 HD FREEdom Edition represents a three-prong solution to the challenges in traditional cardiac CT: 1) Motion FREEdom, with intelligent motion correction via SnapShot Freeze; 2) Calcium FREEdom, with enhanced coronary visualization using Gemstone Spectral Imaging (GSI) Cardiac; and 3) Horizon FREE opportunities, with plaque material composition assessment and accurate perfusion calculations.

“SnapShot Freeze will be a game changer by improving the effective temporal resolution; and from the initial images, I see significantly reduced motion artifacts and significantly improved image clarity” said James Min, director of cardiac imaging research and co-director of cardiac imaging at Cedars Sinai Hospital and current president of Society of Cardiovascular Computed Tomography (SCCT).

SnapShot Freeze can help significantly reduce coronary motion and overcome the inherent limitation of all hardware-only solutions. By precisely detecting vessel motion and velocity, SnapShot Freeze can determine actual vessel position and intelligently correct the effects of motion during cardiac CT exams. Bench-top evaluation of SnapShot Freeze intelligent motion correction has demonstrated that SnapShot Freeze can achieve a 58-millisecond (ms) equivalent gantry rotation speed, which is four to six times faster than hardware-only gantry rotation speed alone. This translates to a 29-ms effective temporal resolution, which achieves for the first time a cardiac CT temporal sampling similar to the frame rate of a cath lab.

“FREEdom Edition has the potential to significantly improve coronary artery imaging with CT,” said Jonathon Leipsic, head of radiology, Providence Health Care at St. Paul’s Hospital in Vancouver, British Columbia. “By intelligently reducing motion artifact in CT images, SnapShot Freeze improves visualization, which may allow for reduction in the number of non-interpretable segments and increases reader confidence of CCTA (coronary computed tomography angiography).”

The FREEdom Edition’s first U.S. installation was at the University of Washington, Seattle. The installation at UW follows around two dozen installations in Europe and Japan, where physicians are currently using SnapShot Freeze and GSI Cardiac in routine practice for coronary evaluation, and pushing the horizons of cardiac CT in plaque composition and myocardial perfusion assessment.

The Discovery CT750 HD FREEdom Edition is also the first cardiac spectral CT scanner that merges GE’s SnapShot Pulse technology with GSI’s fast kV switching, allowing for a registered spectral CT dataset. Spectral CT takes CT beyond anatomy to create images of quantitative material density, which can then be synthesized into monochromatic energies. Monochromatic images have key advantages in virtually beam hardening artifact-free images, and improving contrast-to-noise at a given dose. For the first time, coronary images with calcium suppression are possible for challenging patients with high calcium burden. Additionally, GSI Cardiac enables investigations into new areas of CT coronary plaque assessment and quantitative myocardial perfusion.

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