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November 30, 2008
CHICAGO — November 30, 2008 — As the next phase in validating advanced computed tomography technology in a clinical setting, Toshiba Medical Systems Corporation (TMSC) will support CORE 320, the largest worldwide multi-center trial comparing the effectiveness of 320-detector row dynamic volume CT to SPECT technology. The trial will examine whether the combination of CT angiography and myocardial perfusion can identify coronary stenoses that are less than or equal to 50 percent by Quantitative Coronary Analysis (QCA) and correspond to a SPECT perfusion defect. CORE 320 will begin in December 2008.
The Aquilion® ONE, the dynamic volume CT system to be used in CORE 320, will be showcased at this year’s Radiological Society of North America (RSNA) annual meeting in Chicago, Nov. 30 – Dec. 5, 2008 (Booth #3429, South Hall).
“One of Toshiba’s core missions is to validate its technology through clinical trials by leaders in the medical field,” explained Yusuke Toki, general manager, Clinical Application Research Center, TMSC. “As the first and largest multi-center trial using dynamic volume CT, CORE 320 will result in the most statistically reliable data available on this advanced technology. This will be attributed in part to the trial’s design, which calls for an international, multi-center approach, bypassing the limitations associated with focusing on one geographic area and/or small patient populations.”
CORE 320’s multi-center trial will be lead by primary investigator Dr. João A. C. Lima of Johns Hopkins University School of Medicine, in Baltimore, Md. Johns Hopkins University will also serve as the core site for CT. Dr. Marcelo Di Carli of Brigham and Women’s Hospital, a Harvard teaching hospital, in Boston, Mass. will serve as core site for SPECT. Additional investigation sites will be announced in the coming months.
“We expect CORE 320 findings to impact the way the medical community views the role of dynamic volume CT in the diagnosis and treatment of life-threatening diseases,” explained Toki. “These results eventually could impact they way patients are diagnosed and treated.”
Toshiba believes in developing technology that helps improve patient outcomes and as such, sponsors clinical trials to assure new technology adds true value to the healthcare system and patient. CORE 320 is the next phase of that validation strategy.
Prior to CORE 320, Toshiba funded the CorE 64 (Coronary Evaluation using multidetector 64 CT) trial, an international multi-center trial to validate multidetector CT’s ability to detect coronary artery disease (CAD) as compared to conventional coronary angiography (CCA). On Nov. 26, 2008, the New England Journal of Medicine published the promising results of the CorE 64 trial stating “Multidetector CT angiography accurately identifies the presence and severity of obstructive coronary artery disease and subsequent revascularization in symptomatic patients.”
Another Toshiba trial, faCTor64, the Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following CorE 64: is being conducted at Intermountain Healthcare’s Intermountain Medical Center in Salt Lake City. Intermountain Healthcare is a community-owned system of nonprofit hospitals and clinics based in Salt Lake City. More than 1,000 patients from Utah, women older than 55 years old and men older than 50 years old, are enrolled in the faCTor64 study. Intermountain Healthcare used its diabetes registry of 30,000 patients, who have already received best-practice diabetic care, as a resource to enroll patients. To date, faCTor64 is showing very promising results.
Several additional studies to evaluate the clinical impact of Aquilion ONE are being investigated.
Introduced in November 2007, dynamic volume CT scans an entire organ in a single pass and produces 4D videos that show an organ’s structure, its movement and blood flow. In comparison, a 64-slice, 128-slice or 256-slice CT scan can only capture a portion of an organ in a single pass, requiring physicians to “stitch together” multiple scans of an organ to get a full image. The new technology helps reduce multiple exposures to radiation and exam time.
The Aquilion® CT product line has received numerous accolades including earning the number one ranking in CT from MD Buyline since 2002 (six consecutive years). The Aquilion CT line has also been named Best in KLAS in 2006 and 2007; Best in KLAS in 2008 for 64-detector row and above; and Frost & Sullivan’s “Healthcare Innovation Award in Cardiovascular Imaging” in 2008. For more information about KLAS, visitwww.KLASresearch.com.
The Aquilion® ONE, the world’s first dynamic volume CT, utilizes 320 ultra-high resolution detector rows to image an entire organ in a single gantry rotation and shows dynamic function like blood flow. Since its introduction in November 2007, the Aquilion ONE has been named Popular Science magazine’s “Best of What’s New 2008 — Personal Health Category,” rt Image’s 2008 Most Valuable Product (MVP), Frost & Sullivan’s Global CT Systems Product Differentiation Innovation Award 2007 and AuntMinnie.com’s “Minnies 2008 – Best New Radiology Device.”
With headquarters in Tustin, Calif., Toshiba America Medical Systems markets, sells, distributes and services diagnostic imaging systems, and coordinates clinical diagnostic imaging research for all modalities in the United States. Toshiba Medical Systems Corp., an independent group company of Toshiba Corp., is a global leading provider of diagnostic medical imaging systems and comprehensive medical solutions, such as CT, Cath & EP Labs, X-ray, Ultrasound, MRI and information systems. Toshiba Corp. is a leader in information and communications systems, electronic components, consumer products, and power systems. Toshiba has approximately 198,000 employees worldwide and annual sales of $77 billion. For more information, visit www.medical.toshiba.com.
Aquilion ONE is a trademark of Toshiba Medical Systems Corporation.