GE Healthcare’s FREEdom Edition Receives FDA Clearance,

WAUKESHA, WI – JULY 19, 2012 – As the 2012 Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting opens today in Baltimore, Maryland, GE Healthcare announced 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 performance and to help physicians better serve patients.

Discovery CT750 HD FREEdom Edition offers physicians capabilities that could change the rules of cardiac CT. Based on exclusive FREEdom technologies (Fast Registered Energies & ECG), this innovative system 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, going beyond today's clinical information with plaque material composition assessment and accurate perfusion calculations. Click on the link here to learn more about the FREEdom Edition.

“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 Dr. James Min, Director of Cardiac Imaging Research and Co-Director of Cardiac Imaging at Cedars Sinai Hospital and current President of SCCT.

SnapShot Freeze, one of FREEdom’s innovative technologies, 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 58msec Equivalent Gantry Rotation Speed, which is 4 to 6 times faster than hardware-only gantry rotation speed alone. This translates to a 29msec 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 Dr. Jonathon Leipsic, Head of Radiology, Providence Health, St. Paul’s Hospital in Vancouver. “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.”

The HD FREEdom Edition’s first U.S. installation was at the University of Washington, Seattle. According to Dr. William Shuman, Vice Chair and Medical Director of the Department of Radiology at University of Washington Medical Center at Seattle: “Our physicians have already been using GSI routinely in body and vascular imaging, and we are excited to extend those benefits with FREEdom Edition to cardiovascular Spectral CT.”

HD FREEdom’s 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 pioneering 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 improved contrast-to-noise at a given dose. And “Calcium FREEdom” means that 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 horizons of CT coronary plaque assessment and quantitative myocardial perfusion.

GE’s Discovery CT750 HD leads the industry in cardiac CT spatial resolution at 18.2 lp/cm^. This level of resolution helps physicians make a confident diagnosis and accurately quantify stenoses in coronary vessels by displaying reduction in calcium blooming compared to standard resolution.

GE Healthcare’s continued leadership in cardiac imaging was recently highlighted when the Discovery CT750 HD was included in the first ever fully positive recommendation from the UK’s National Institute for Health and Clinical Excellence (NICE) Diagnostic Assessment Programme, which aims to ensure the National Health Service can rapidly and consistently adopt clinically and cost effective technologies. NICE recommended the Discovery CT750 HD scanner as an option for first line cardiac imaging of the coronary arteries in people with suspected coronary artery disease.

“We believe the traditional challenges of cardiac CT are in large part beatable with a smarter software and electronic approach,” said Steve Gray, Vice President and General Manager for CT and Advantage Workstation at GE Healthcare. “FREEdom Edition offers physicians a new tool to help overcome coronary motion, and various artifacts that may stand in the way of a highly accurate, confident cardiac diagnosis in a variety of clinical settings.”

FREEdom Edition is built on the robust and proven Discovery CT750 HD platform. Installed in hundreds of medical institutions around the globe, this system is powered by GE's exclusive HD and low dose technologies, including GSI for lesion characterization and proven Adaptive Statistical Iterative Reconstruction (ASiR) dose-optimizing technology already used on over 12 million scans at 1,200 sites worldwide+.

* Trademark of General Electric Company.

^ Based upon internal test data comparing Discovery CT750 HD cardiac half-scan spatial resolution to data from Advanced CT Scanners for Coronary Angiography, ImPACT Report CEP10043, March, 2010 available at http://impactscan.org .

+ In clinical practice, the use of ASiR may reduce CT patient dose depending on the clinical task, patient size, anatomical location and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task


About GE Healthcare:
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

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