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July 13, 2005
Contrast Agent Isovue®-370 (iopamidol injection 76%) Used in International Investigation Assessing Multislice CT for Diagnostic Cardiac Imaging
PRINCETON, NJ, July 13, 2005 – Bracco Diagnostics Inc. announced today it has partnered with Toshiba Medical Systems Corporation in supporting a landmark clinical trial aimed at assessing the viability of using multislice computed tomography (CT) as a primary diagnostic tool for detecting cardiovascular diseases and disorders, in comparison to cardiac catheterization.
The study, named “CorE 64” for “coronary evaluation on 64” is the first multi-center clinical study to focus specifically on computed tomography angiography (CTA) using 64-slice CT technology. Patient evaluations are expected to take place for several months, and initial study results are planned for release in 2006.
Bracco’s contrast agent Isovue®-370, the highest concentration iodine agent approved for CT imaging in the United States, will be provided for non-invasive diagnostic imaging of cardiac patients in conjunction with Toshiba CT technologies, including the AquilionTM CFX 64-slice CT scanner, the 64-row Quantum Detector, as well as SURECardioTM and SUREPlaqueTM applications.
According to Bracco Diagnostics Inc. President and Chief Executive Officer Carlo Medici, the study will be a highly important benchmark in assessing one of the fastest growing CT applications in the diagnostic imaging arena.
“Bracco firmly believes that this is a necessary endeavor, and that cardiologists and radiologists need a large-scale, controlled study to accurately gauge the viability of Coronary CTA, clarify much of the prevailing hype, and perhaps instill greater confidence in this diagnostic imaging application,” said Medici. “We are proud to work with Toshiba Medical Systems Corporation in this regard, because Bracco places a priority focus on supporting clinical research that addresses specific market issues and helps move the process of innovation in diagnostic imaging forward.”
According to Bracco, Isovue-370 was selected for the trial because it is the only product in the US market that is approved at this iodine concentration (370mgI/ml) for CT. The use of high iodine nonionic agents in conjunction with multi-slice CT equipment is already widely accepted amongst the imaging community. High concentration agents can provide the necessary iodine delivery rate (IDR) safely and still match the power and speed of 64-slice CT scanners.
In the study, CTA will be used to visualize soft plaque, measure coronary stenosis, plan quantitative treatment, and calculate plaque burden.
The use of CT cardiac imaging is already growing exponentially throughout the world, as is the implementation of multislice CT scanners. In 2004, approximately 6 percent of all diagnostic coronary procedures were performed with CT, and Bracco estimates substantial continued growth in the next five years. It is estimated that 95 percent of all CT scanners purchased today are multidetector scanners.
“64-MDCTA has an obvious potential in the care of patients with coronary artery disease; however, for that potential to be realized we need to demonstrate comparability with conventional angiography in a multi-center format,” said Joao A. C. Lima, MD, Associate Professor of Medicine and Radiology, and Director of Cardiovascular Imaging in Cardiology at Johns Hopkins University. “This study is therefore crucial and Bracco’s participation a very important asset in making the study a success.”
The study involves a number of esteemed health care institutions from throughout the world, including the Johns Hopkins University School of Medicine, Beth Israel Deaconess Medical Center, Leiden University Medical Center in the Netherlands, Humboldt University, Campus Charité Mitte in Germany, INCOR Heart Institute of the School of Medicine Hospital, Sao Paolo University in Brazil, and Iwate Medical University in Japan.
With headquarters in Tustin, California, 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 Corporation, an independent group company of Toshiba Corporation, is a global leading provider of diagnostic medical imaging systems and comprehensive medical solutions such as CT, X-ray, Ultrasound, nuclear medicine, MRI and information systems. Toshiba Corporation is a leader in information and communications systems, electronic components, consumer products, and power systems. Toshiba has approximately 162,000 employees worldwide and annual sales of $55 billion.
Bracco launched Isovue (iopamidol injection), the first ready-to-use, nonionic contrast agent, in 1981. In the US, Isovue is approved for a wide range of diagnostic and interventional indications. It is available in concentrations of 200, 250, 300 & 370mgI/ml. It is one of the market leading nonionic agents sold in the US and remains the nonionic agent of choice for thousands of clinicians world-wide.
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. As with all injectable contrast agents, the possibility of severe reactions should be borne in mine, regardless of the patient’s pre-existing medical history.
The Bracco Group is a world leading provider of global diagnostic imaging solutions, with net sales of about $1.25 billion. Bracco has operations in 115 countries and about 3,300 employees, around 600 of whom work in R&D. Bracco invests approximately 15% of its annual turnover in R&D and has a portfolio of 1,500 patents worldwide.
The Bracco Group is a leader in the diagnostic imaging market with an integrated product offering from a diverse roster of subsidiary companies. While Bracco is recognized internationally as a definitive market leader in its core business of contrast media, Bracco also markets key diagnostic imaging resources through the following companies: Esaote, which is one of the world’s primary producers of magnetic resonance and ultrasound imaging systems; ACIST Medical Systems, a manufacturer of advanced contrast media injection systems; EBIT-AET, which creates and markets medical application software, and Singapore-based Volume Interactions, which also produces advanced medical software.
Bracco also operates a high-level international research network, with three centers (Milan, Geneva, and Princeton). These centers develop products of the latest-generation diagnostic techniques, from X-ray and computed tomography (CT) to magnetic resonance imaging (MRI) and echocontrast.
*Isovue is a registered trademark of Bracco. Aquilion, SURECardio, and SUREPlaque are trademarks of Toshiba Medical Systems Corporation.
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