Landmark European Trial Further Demonstrates That Cardiac Resynchronization Therapy (CRT) Reduces Morbidity and Mortality in Patients with Heart Failure.

BARCELONA, Spain -- CARE-HF data presented at the ESC show that CRT significantly reduced all-cause mortality, heart failure death and sudden cardiac death and is equally effective in patients with diabetes

Further analysis of data from the CARE-HF (Cardiac Resynchronization in Heart Failure) study presented today at the 2006 European Society of Cardiology (ESC)/World Congress of Cardiology (WCC) demonstrate that Cardiac Resynchronization Therapy (CRT) significantly reduces mortality in heart failure (HF) patients.(1,2) Each year more than 2 million patients worldwide are diagnosed with heart failure, a condition in which the heart cannot meet the energy demands of the body.(3,4)

The CARE-HF data presented today show that CRT reduced all-cause mortality including significant reduction in heart failure death as well as sudden cardiac death, which together account for one-third of overall deaths in patients with heart failure.(1) Additionally, CRT also reduced all-cause mortality in patients with moderate to severe heart failure and diabetes to a similar extent of that in patients without concomitant diabetes.(2)

"From previous CARE-HF data, we already knew that CRT improves survival in heart failure patients," said Uta C. Hoppe, MD, Department of Medicine III, University of Cologne, Germany. "With these new data, we now have proof that CRT is beneficial in heart failure patients with different co-morbidities, including those at risk of sudden cardiac death and patients with diabetes."

An analysis of the CARE-HF study was performed to determine the causes of death and the predictors of sudden cardiac death (SCD) in heart failure patients. The results of the analysis presented today show that the use of CRT decreased this risk of HF death by 45 percent and SCD by 53 percent and supports the concept that it is the improvement in cardiac function with CRT that leads to the reduction in SCD.(1) Hundreds of thousands of people worldwide are at risk of sudden cardiac death every year.(5,6)

The other analysis presented today showed that patients with diabetes and heart failure seem to benefit equally from CRT as patients with heart failure and without diabetes. CRT reduced the mortality rate in patients with diabetes by 39 percent; comparably, CRT reduced the mortality rate in patients without diabetes by 40 percent.(2) Diabetes mellitus and heart failure often coexist - patients with diabetes have an up to five-fold increased risk of developing cardiovascular disease.(7)

"This analysis not only provides better understanding about the positive impact of CRT on the important group of heart failure patients with diabetes," explained Dr. Hoppe, "but also confirms findings from other recent analysis from the CARE-HF study that showed an overall similar beneficial impact of CRT in different groups of heart failure patients, such as those with concomitant ischemia and atrial fibrillation."

CARE-HF - Sudden cardiac death (SCD) analysis

For this analysis, the patients in the CARE-HF study were analysed to determine factors predicting SCD during long-term follow-up. The CARE-HF study showed that CRT reduced mortality in HF patients with ventricular dyssynchrony by 36 percent during a mean follow-up of 29.4 months, but without significant decrease in SCD; however, in the planned extension phase, mean follow-up of 36.4 months, with an all-cause mortality reduction of 40 percent, SCD was significantly reduced. The analysis showed improvements in parameters of cardiac function and supports the concept that it is this improvement in cardiac function with CRT that leads to the reduction in lethal arrhythmias and SCD.(1)

CARE-HF - Diabetes mellitus (Dm) analysis

For this analysis, the impact of diabetes mellitus was studied by distribution of the patients (207 participants, 25.9 percent) between the CRT group and the medical therapy group. The relative benefits of CRT were similar in patients with and without diabetes for a number of outcomes. In patients with diabetes, CRT also reduced the risk for all predefined combined endpoints, such as death or unplanned hospitalisation for a cardiovascular event or death from any cause or unplanned hospitalisation with worsening heart failure, and improved New York Heart Association (NYHA) class and quality of life. In addition, no interaction between diabetes and CRT was observed for any outcome.(2)

Medtronic, Inc. (www.medtronic.com - NYSE:MDT), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Notes to the editor:

The CARE-HF study is a multi-centre, international, randomised trial supported by Medtronic designed to evaluate the long-term effects of CRT on mortality and morbidity among moderate and severe heart failure patients. CARE-HF is a prospective analysis based on the intention to treat data from all patients enrolled in the CARE-HF trial at 82 clinical centres in 12 European countries. A total of 813 patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony were randomly assigned to pharmacology therapy alone or with the addition of CRT.

CRT resynchronizes the contractions of the heart's ventricles by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently. CRT defibrillators (CRT-D) also incorporate additional lifesaving therapy to quickly terminate an abnormally fast, life-threatening heart rhythm. CRT and CRT-D have become increasingly important therapeutic options for patients with moderate and severe heart failure since Medtronic first began clinical evaluation of its CRT systems in 1997.

References:

1. B. Uretsky, J Cleland, N. Freemantle, et al., "Predictors of arrhythmic sudden cardiac death in heart failure patients in the CARE-HF study" presented at the European Society of Cardiology meeting on 3 September 2006 in Barcelona.

2. U. Hoppe, M. Marijianowski, N. Freemantle, et al., "Effect of cardiac resynchronization on morbidity and mortality of diabetic patients with severe heart failure" presented at the European Society of Cardiology meeting on 3 September 2006 in Barcelona.

3. Datamonitor. The Future Decoded, Table 1 Prevalence of chronic heart failure and incidence of acute heart failure in the major markets 2001.

4. American Heart Association, "Understanding heart failure," retrieved from, http://www.americanheart.org/presenter.jhtml?identifier=1593, on 22 August 2006.

5. D P Zipes. Epidemiology and mechanism of sudden cardiac death. Can J Cardiol. Vol 21, Suppl. A, May 15 2005.

6. S G Priori, E Aliot, c Blomstrom-Lundqvist et al. Task force of sudden cardiac death, European Society of Cardiology, Summary of recommendations. Europace, 2002;4:3-18.

7. Yudkin JS, et al. Prevention and management of cardiovascular disease in patients with diabetes mellitus: an evidence base. Diabetic Medicine (1996); 13 (supplement 4): S101-S121 UK Prospective Diabetes Study Group.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.