New Analysis Provides Additional Support for the Cost-Effectiveness of Cardiac Resynchronization Therapy (CRT) for Patients with Heart Failure.

BARCELONA, Spain -- Health Economic Research Presented at the ESC meeting, Based on the Previously Published CARE-HF Trial Reinforcing the Medical Efficacy of CRT, Demonstrates the Cost-Effectiveness of Both CRT and CRT-D 

According to data presented today at the 2006 European Society of Cardiology (ESC)/World Congress of Cardiology (WCC), long-term treatment with Cardiac Resynchronisation Therapy (CRT) or CRT-D (with an implantable cardioverter defibrillator or ICD) is a cost-effective way to improve survival in patients with heart failure. In addition, further analysis of data from the CARE-HF study, which demonstrates that CRT reduces mortality in heart failure patients, have also been presented at ESC.(1)

Heart failure affects more than 22 million people and accounts for nearly EUR 64 billion ($80 billion) in cost each year worldwide.(2) It is also a leading cause of hospitalisation among people aged 65 years and older, and admissions for its symptoms have increased by 155 percent over the last 20 years.(3)

"The CARE-HF study provides conclusive evidence that, for patients with moderate or severe heart failure, CRT is a treatment that both improves symptoms and reduces mortality, a finding that is further supported by a meta-analysis of reported studies," stated Professor John Cleland, chairman of the CARE-HF steering committee and head of the Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hill, United Kingdom. "An analysis of cost-effectiveness, using data from both the CARE-HF and COMPANION studies, shows that both CRT and CRT-D are highly cost-effective in patients with moderate or severe heart failure."

The cost-effectiveness of CRT is based on the proven clinical evidence of improvements in quality of life, morbidity, mortality, and reduction in costs associated with hospitalisation for heart failure. The cost-effectiveness of CRT-D is based on similar benefits with the additional advantage of preventing a high proportion of sudden cardiac deaths. Thus, CRT can reduce deaths from worsening heart failure and lower the rate of sudden cardiac death to some extent, and the ICD can significantly reduce sudden cardiac deaths further.(1)

"CRT-D also appears a cost-effective option, provided there is reasonable certainty that the patient is unlikely to die from non-cardiac causes within the next five to 10 years," added Cleland. "Thus, for younger patients with heart failure who do not have serious non-cardiac co-morbidity such as respiratory disease, cancer or end-stage renal failure, CRT-D may be the best choice. Extending life meaningfully, both in terms of quality and duration, is important when considering whether to use CRT-D rather than CRT."

The results demonstrate that the incremental cost-effectiveness is EUR 7,614 (GBP 5,128/$9,798) for CRT and EUR 18,199 (GBP 12,257/$23,419) for CRT-D when compared with optimal medical therapy per quality adjusted life year (QALY), which is substantially lower than the threshold of EUR 44,542 (GBP 30,000/$57,305) per QALY estimate that is widely considered to be acceptable value for cost effectiveness.(1)

The analysis was conducted from a life-time perspective and based on cost data obtained from the UK, data from the CARE-HF trial, and by making the assumption that adding a defibrillator to CRT would reduce the risk of sudden, presumed arrhythmic death by a similar amount observed in the COMPANION study. Other parameters and endpoints used in this analysis, including New York Heart Association (NYHA) class distribution, associated health utilities, rates and cause of hospitalisation and death, were estimated from individual patient data from the CARE-HF trial and published literature.(1)

Additional data presented today based on analyses conducted for the Italian and Spanish healthcare systems further support the cost effectiveness of CRT compared to optimal medical therapy.(4,5)

"On average treating patients with heart failure costs 1 to 2 percent of the healthcare budget of developed countries," stated Peter Steinmann, vice president for the Medtronic Cardiac Rhythm Disease Management business in Western Europe. "CARE-HF was designed, conducted and analysed by an independent group of leading experts in the field of heart failure and electrophysiology. We are pleased to support this milestone study to provide access to an effective treatment enabling patients with heart failure to extend and improve their quality of life."

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 editors:

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 patients with moderate and severe heart failure. 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. The results of this trial demonstrated a 36 percent reduction in all cause mortality and a 52 percent reduction in heart failure hospitalisations.

CRT resynchronizes the contractions of the heart's chambers by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently. CRT defibrillators also incorporate additional lifesaving therapy to quickly terminate an abnormally fast, life-threatening heart rhythm. CRT and CRT defibrillators 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. N. Freemantle, G. Yao, M. Calvert, S. Bryan, J. Daubert, J. Cleland, "The cost-effectiveness of CRT with or without an ICD: Cost effectiveness based upon CARE-HF trial" presented at European Society of Cardiology meeting on 5 September 2006 in Barcelona.

2. Medtronic data on file

3. Mayo Clinic, "Aging Population, Longer Survival with Disease Magnify Heart Failure Epidemic," retrieved from, http://www.mayoclinic.org/news2004-rst/2353.html, on 22 August 2006.

4. M. Frigerio, L. Yao, M. Lunati, et al., "The long-term cost-effectiveness of CRT: A model based analyses based on the results from the CARE-HF trial from the Italian Healthcare perspective" presented at European Society of Cardiology meeting on 5 September 2006 in Barcelona.

5. J. Caro, "Modeling the Economic and Health Consequences of CRT in Spain" presented at European Society of Cardiology meeting on 5 September 2006 in Barcelona.

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.