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Contact: ACIST Medical Systems

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A newly released retrospective observational study shows that use of lower volumes of contrast media while using the ACIST Contrast Delivery System is associated with a reduced relative risk of Contrast Induced Nephropathy (CIN) when compared to traditional hand injection methods.

Minneapolis, MN, December 14, 2006 – ACIST Medical Systems, leading the market in variable-rate, automated contrast delivery systems used in cardiac and vascular angiography, announced the recent publication of a clinical study which showed that use of lower volumes of contrast media while using the ACIST Contrast Delivery System was associated with a reduced relative risk of Contrast Induced Nephropathy (CIN). The study, Automated Contrast Injection in Contemporary Practice during Cardiac Catheterization and PCI: Effects on Contrast-Induced Nephropathy, by Jason Call, et al, was published in the October 2006 issue of the Journal of Invasive Cardiology (Volume 18, Number 10, pages 469-474.) This study is believed to be “the first study to demonstrate that methods to reduce contrast use and strategies to minimize CIN are associated with a lower incidence of CIN and Acute Renal Failure (ARF) after diagnostic catheterization and PCI procedures,” according to the study authors.

This retrospective, observational study involved 2,175 patients from April 2002 through November 2004 who underwent coronary catheterizations and PCI procedures at Wake Forest University Baptist Medical Center in North Carolina. Data were compared between patients undergoing traditional hand injection methods (n=1798) and those who were treated using the ACIST variable-rate, automated contrast injection method (n= 377), to reduce contrast volumes, in conjunction with contemporary strategies of hydration and N-acetylcysteine use. It was found that the use of the ACIST to reduce contrast volume in conjunction with strategies to minimize CIN was associated with a significant reduction in the incidence of CIN. The study demonstrated a 28% reduction in contrast volume, a 31% lower incidence of CIN, and a 49% lower incidence of acute renal failure, when compared to traditional hand injection methods.

CIN is associated with significant economic and clinical consequences, including prolonged hospitalization, the requirement for dialysis, and an increased risk of death.1 In susceptible patients, CIN is first noticed 24 to 72 hours after contrast exposure, and typically becomes most severe five to seven days later. CIN is particularly more likely to occur in those with preexisting renal disease or diabetes. While renal function often returns to normal over the next 2 weeks, clinical studies have shown that CIN is associated with significant increases in morbidity, and mortality after coronary angiography2-5. In the study by Call et al, the risk of CIN was correlated with the dose of contrast injected into the patient. Use of the ACIST Contrast Delivery System was associated with a significant reduction in contrast dose compared to the traditional, older method of hand injection of contrast using a standard syringe.

“We are pleased with the results of this important study.” states Fulvio Renoldi Bracco, Chairman of ACIST. “We believe this recent publication, in addition to the previously published clinical literature5-15, helps convey the important role that ACIST Contrast Delivery Systems play in today’s modern world of cardiac and vascular angiography.”

About ACIST

ACIST is a world leader in contrast delivery solutions for the imaging field, dedicated to advancing the art of angiography through research and development of new products and technologies – supporting today’s needs and anticipating those of tomorrow. More than four million people around the world have had cardiovascular angiographic procedures using an ACIST system, now at over 1 million annually – and growing. ACIST systems are widely proven in the global health care arena, with clinical usage in over 30 countries and in many world-renowned centers, as well as in community hospitals and university settings.

About Bracco

The Bracco Group is a world leading provider in diagnostic imaging, with net sales of about 800 million Euros per year. Bracco has operations in 115 countries and about 2,100 employees, around 300 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: ACIST Medical Systems, a manufacturer of advanced contrast media injection systems and Singapore-based Volume Interactions, which also produces advanced 3-D medical software.

Bracco also operates a high-level international research network, with three centers (Ivrea, Geneva, and Princeton). These centers develop products of the latest-generation diagnostic techniques, from X-ray and computed tomography (CT), magnetic resonance imaging (MRI), echocontrast and nuclear medicine.

AngioTouch is a registered trademark of ACIST Medical Systems.

References
1. Wiebe N, Pannu N, Wiebe N, Tonelli M. Prophylaxis Strategies for Contrast-Induced Nephropathy. Journal of the American Medical Association 2006; 295:2765-2779.

2. Murphy SW, Barrett BJ, Parfrey PS. Contrast nephropathy. J Am Soc Nephrol 2000; 11:177-182.

3. Gutierrez N, Diaz A, Timmis GC, et al. Determinants of serum creatinine trajectory in acute contrast nephropathy. J Interv Cardiol 2002; 15: 349-354.

4. Rihal CS, Textor SC, Grill DE, et al. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation 2002; 105: 2259-2264.

5. Barrett BJ, Parfrey PS. Clinical practice. Preventing nephropathy induced by contrast medium. N Engl J Med 2006; 354:379-86. ACIST Clinical References

6. Anne G, Gruberg L, Huber A, Nikolsky E, Grenadier E, Boulus M, Amikam S, Markiewicz M, Beyar R.Traditional versus automated injection contrast system in diagnostic and percutaneous coronary interventional procedures: Comparison of the contrast volume delivered. Journal of Invasive Cardiology 2004; 16:360-362.

7. Lehmann C, Hotaling M., Saving time, saving money: A time and motion study with contrast management systems. Journal of Invasive Cardiology 2005; 17(2):118-121.

8. Khoukaz S, Kern MJ, Bitar SR, Azrak E, Eisenhauer M, Wolford T, El-Shafei Amr. Coronary angiography using 4 Fr catheters with ACISTed power injection: A randomized comparison to 6 Fr manual technique and early ambulation. Catheterization and Cardiovascular Interventions 2001; 52:393-398.

9. Chahoud G, Khoukaz S, El-Shafei A, Azrak E, Bitar S, Kern MJ. Randomized comparison of coronary angiography using 4F catheters: 4F manual versus “ACISTed” power injection technique. Catheterization and Cardiovascular Interventions 2001; 53(2):221-224.

10. Brosh D, Assali A, Fuchs S, Teplitsky I, Shor N, Kornowski R. The ACIST Power Injection System reduces the amount of contrast media delivered to the patient, as well as fluoroscopy time during diagnostic and interventional cardiac procedures. International Journal of Cardiovascular Interventions 2005; 7(4):183-187.

11. Goldstein JA, Kern M, Wilson R. A novel automated injection system for angiography. Journal of Interventional Cardiology 2001; 14:147–152.

12. Lim MJ. Early ambulation strategies with contrast management. Journal of Invasive Cardiology 2005; 17(1):42-43.
13. Kern MJ. Interventional and peripheral vascular procedures using contrast management: Tips and techniques. Journal of Invasive

Cardiology 2004; 16(12):729-731.
14. Laird JR. Contrast delivery and patient safety during peripheral interventions. Journal of Invasive Cardiology 2006; 18(Suppl A):

21A-25A.

15. Allie DE, Hebert CJ, Walker CM. Automated Contrast Injection and Targeted Renal Therapy: Strategies to Prevent Contrast- Induced Nephropathy and Treat Renal Insufficiency in Patients with Peripheral Arterial Disease. Vascular Disease Management 2006; 3(3):1-7.

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