FDA Panel Recommends Approval of Medtronic's InSync System for Treatment of Heart Failure; New Cardiac Resynchronization Therapy Moves Toward Final Approval.

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MINNEAPOLIS--(BUSINESS WIRE)--July 10, 2001

Medtronic, Inc. (NYSE:MDT), announced today that its InSync(R) cardiac resynchronization system for the treatment of moderate and severe heart failure with left ventricular dysynchrony received a unanimous recommendation for approval with post-market conditions by the Circulatory Devices Panel of the United States Food and Drug Administration (FDA). The panel's recommendation will be reviewed by FDA for a final market approval decision.

The Multicenter InSync Randomized Clinical Evaluation trial, known as MIRACLE, evaluated the safety and the therapeutic benefits of the Medtronic InSync(R) Model 8040 atrial synchronous biventricular pacing device, the Model 9880E software and the Attain(TM) LV and Attain(TM) CS pacing leads, in delivering cardiac resynchronization therapy. Data from the study presented to the FDA panel showed that the study met all of its primary endpoints, that cardiac resynchronization therapy delivered by the InSync system is safe, and that it:

-- Improved patient quality of life,

-- Increased exercise tolerance,

-- Improved functional status as assessed the physician.

"The InSync system constitutes one of the most significant new therapies ever developed for the treatment of heart failure," said Dr. William Abraham, lead clinical investigator for the MIRACLE trial and the principal presenter in today's FDA panel meeting. "InSync provides substantial benefits over and above standard drug therapy to Class III and IV heart failure patients with left ventricular dysynchrony, who are among the sickest patients within the healthcare delivery system."

Heart failure is a major and growing health problem, with nearly 5 million Americans currently diagnosed, and more than 500,000 new cases each year contributing to the estimated $38 billion to $40 billion expended to manage the disease in the United States alone. Up to 15 percent of all heart failure patients could benefit from cardiac resynchronization therapy - about 750,000 in the United States. Of these, approximately 87 percent are currently not indicated for implantable cardioverter defibrillator (ICD) therapy and would, therefore, be primary candidates to receive the InSync system.

"The InSync CRT system recommended by the FDA Panel today is designed for an entirely new patient population, one that is not indicated for either an ICD or a pacemaker," said Steve Mahle, president, Cardiac Rhythm Management. "The availability of the InSync system, pending FDA approval, should give new hope to thousands of heart failure patients and their loved ones, who struggle daily to cope with this debilitating illness."

Results presented to the FDA panel reflected the experience of 579 enrolled patients, 532 of whom were implanted with the device and then randomized to either the control group or to therapy. Forty four (44) centers, 39 in the United States and five in Canada, provided data used in the study. Efficacy endpoints were based on 461 randomized patients, of whom 345 completed a six-month follow up. Patients were required to be stabilized on heart failure medical therapy before enrollment and to maintain stable heart failure regimen during the randomized evaluation period, thus diminishing potential confounding effects on the impact of cardiac resynchronization therapy on the study's objectives. Results of the MIRACLE study showed that the InSync system:

-- Improved exercise capacity, as evidenced by an increase in

six-minute hall walk distance and an increase in exercise

time;

-- Improved New York Heart Association (NYHA) functional class;

-- Improved Quality of Life, as measured by the Minnesota Living

With Heart Failure Questionnaire; and,

-- Reduced the number of days hospitalized.

In addition, improvements in several measures of patients' heart failure status and cardiac performance, suggestive of improvement in certain aspects of myocardial function, were observed, including: increased peak oxygen consumption ( peak VO2 ), increased left ventricular ejection fraction (LVEF), reduction in severity of mitral regurgitation and reduction in QRS duration.

The MIRACLE study also measured changes in a composite response that takes into account the following factors: patient survival, hospitalizations for heart failure, patients' own assessment of their heart failure status, changes in NYHA class and other characteristics. Sixty-three (63) percent of patients receiving cardiac resynchronization therapy showed improvement as measured by this composite response, compared to 38 percent in the control group.

"There were no measures of efficacy for which the control group did better than the treatment group," said Dr. Abraham. "Measures of effectiveness that are generally viewed as resistant or less susceptible to placebo effect (e.g., six-minute hall walk, metabolic exercise testing, echocardiographic assessment of left ventricular structure and function) were significantly improved. The improvements in left ventricular ejection fraction and ventricular volumes demonstrated in this study represent a further improvement over those achieved with standard heart failure medications."

The InSync, the InSync III and the InSync ICD cardiac resynchronization systems, along with several models of Attain leads, are commercially available in Europe. InSync, InSync ICD and InSync III devices, along with the Attain leads, are currently under clinical evaluation in the United States.

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

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 30, 2000. Actual results may differ materially from anticipated results.