CARE-HF Study Shows Cardiac Resynchronization Therapy Saves Lives and Reduces Hospitalizations among Many Heart Failure Patients

American College of Cardiology Annual Scientific Session

ORLANDO, Fla.--(BUSINESS WIRE)--March 7, 2005--

Results presented at ACC and published in The New England Journal of Medicine

Cardiac resynchronization therapy (CRT) in patients with moderate or severe heart failure and poor heart pumping function saves lives and reduces cardiovascular hospitalization, according to results of a landmark study announced by Medtronic, Inc. (NYSE:MDT). Findings from the CARE-HF (Cardiac Resynchronization in Heart Failure) randomized, controlled trial were presented today during a Late-Breaking Clinical Trial session at the American College of Cardiology Annual Scientific Session and concurrently published in The New England Journal of Medicine.

Study results, which were consistent across patient sub-groups, showed the following outcomes for patients who received a Medtronic CRT pacemaker and optimal medical therapy:

-- A 37 percent reduction in combined all-cause mortality (death) or unplanned cardiovascular hospitalization (primary end-point).

-- A 36 percent reduction in all-cause mortality (secondary end-point).

-- Reduced heart failure hospitalizations and improved heart failure symptoms and quality of life (measured by Minnesota Living with Heart Failure questionnaire patient responses).

"We now have overwhelming evidence that cardiac resynchronization therapy saves lives, slows the progression of heart failure, and improves symptoms and morbidity in many heart failure patients; these results add to previous study results demonstrating improvement in heart failure symptoms and quality of life with CRT," said Professor John G. F. Cleland, chairman of the CARE-HF steering committee and head of the Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hull, United Kingdom. "The presentation of CARE-HF findings and publication in The New England Journal of Medicine provide further validation that CRT should be considered as a routine therapy for people with advanced heart failure and cardiac dysynchrony."

The CARE-HF study, sponsored by Medtronic, is a prospective, multi-center, randomized study of patients with NYHA Class III or IV heart failure, wide QRS (QRS greater than or equal to 120ms) and poor heart pumping function (low ejection fraction or EF less than or equal to 35%). Patients studied in this trial had a poorly functioning left ventricle, the heart's main pumping chamber, and received optimal heart failure medical therapy (i.e., ACE inhibitors and beta blockers). For an average of 29 months, CARE-HF investigators followed 813 patients at 82 clinical centers in 12 European countries. A Medtronic InSync(R) or InSync(R) III CRT device was implanted in 409 patients, and 404 patients were in the control group. Unlike previous trials, CARE-HF was of sufficient patient sample size and duration to assess the impact of CRT alone (no defibrillator component) on mortality.

"I expect these impressive CARE-HF findings - which demonstrate significant advantages distinct from the important lifesaving benefits of defibrillation therapy in these patients - will increase the use of both CRT and CRT defibrillator systems in the treatment of many patients suffering from heart failure," said Steve Mahle, president of Medtronic Cardiac Rhythm Management.

Mahle added, "More than 13 years ago, Medtronic set out to lead the way to improve treatment options and clinical outcomes for the millions of people worldwide who suffer from heart failure symptoms and have a poor prognosis despite optimal drug therapy. The company has supported more than 20 heart failure clinical studies following more than 9,000 patients worldwide to evaluate the potential of device-based therapies to treat heart failure. CARE-HF, together with studies such as Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), demonstrates Medtronic's leadership in and commitment to heart failure clinical research to improve and save patient lives."

Other major clinical trials supported by Medtronic such as MUSTIC, MIRACLE and MIRACLE ICD have shown dramatic benefits of CRT for many heart failure patients, including improved exercise capacity, quality of life and clinical symptoms.

Heart failure affects more than 22 million people worldwide, including 6 million in Europe and 5 million in the United States, with approximately 550,000 new patients diagnosed each year. It is the only cardiac condition that is increasing in prevalence and is a major cost and quality of life issue, characterized by frequent hospitalizations. Heart failure hospitalizations account for nearly $80 billion worldwide in costs each year.

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. It has become an increasingly important therapeutic option for patients with moderate and severe heart failure since Medtronic first began clinical evaluation of the InSync system in Europe in 1997. Today, more than 200,000 heart failure patients worldwide have been treated with a CRT device or CRT defibrillator (all manufacturers).

Medtronic plans to submit results of the CARE-HF study to various regulatory agencies worldwide to request an expanded labeling for its CRT devices.

The CARE-HF study objectives, design and end-points can be referenced in the European Journal of Heart Failure, 3 (2001): 481-489. A description of the baseline patient characteristics and the impact of CRT on health-related quality of life were published in the European Journal of Heart Failure, 7 (2005): 205-214; 243-251. Additional information about the study can be found at www.care-hf.org.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

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 30, 2004. Actual results may differ materially from anticipated results.

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