FDA Panel Recommends Approval of Medtronic's InSync ICD System for Treatment of Heart Failure.

Business Editors & Health/Medical Writers

MINNEAPOLIS--(BW HealthWire)--March 5, 2002

Medtronic, Inc., (NYSE:MDT) announced today that its InSync(R) ICD system has received a recommendation for approval, with conditions, by the Circulatory System Devices panel of the United States Food and Drug Administration (FDA). The InSync ICD system combines cardiac resynchronization therapy and defibrillation therapy in a single device for the treatment of moderate to severe heart failure in patients who have left ventricular dysynchrony and who are at risk for potentially lethal ventricular arrhythmias.

Of the 5 million Americans currently diagnosed with heart failure, approximately 750,000 are candidates for the already-approved cardiac resynchronization therapy (CRT) currently available with the InSync(R) system. Of those, an estimated 100,000 have a ventricular arrhythmia indication (VT/VF) and could be candidates for InSync ICD. If the FDA takes the recommendation of the panel, final market approval of the InSync ICD system will provide CRT and ICD therapies to this segment of the growing heart failure population.

"Thousands of people need both cardiac resynchronization therapy and the protection of a defibrillator," said Dr. James Young, principal presenter at the FDA panel meeting. "Approval of InSync ICD will expand the options for heart failure patients with a therapy choice that is now proven through clinical study to offer them a better quality of life and the safety of ICD therapy."

Clinical data presented to the FDA panel today demonstrated that, for New York Heart Association (NYHA) Class III/IV patients with ventricular dysynchrony and an indication for ICD therapy, the InSync ICD study met all of its primary safety objectives, and demonstrated:

-- Improved Quality of Life assessment, as measured by the Minnesota Living
With Heart Failure Questionnaire;

-- Improved exercise capacity, as measured by cardiopulmonary exercise testing;


-- Improved functional status, as measured by the clinical composite response
that considered mortality, hospitalization for heart failure and worsening NYHA
heart failure classification.

The MIRACLE (Multicenter InSync Randomized Clinical Evaluation) ICD trial, led by Dr. Young, evaluated the safety and therapeutic benefits of the Medtronic InSync ICD (Model 7272) device and the Attain(TM) SD (Model 4189) left-heart lead. The Attain SD lead is a 4 French, steroid-eluting left-heart lead designed to navigate into small cardiac veins with tight pathways, adding an additional lead choice to meet clinical needs and physician preferences.

"With the InSync ICD system, we will be able to offer physicians and patients another proven therapy option in the battle against this complex disease called heart failure," said Steve Mahle, president, Medtronic Cardiac Rhythm Management. "Pending final FDA approval, InSync ICD will join InSync and the Attain family of leads in the growing suite of Medtronic products designed to help physicians treat heart failure patients."

MIRACLE ICD results presented to the FDA panel reflected the experience of 362 patients with moderate to severe heart failure, ventricular dysynchrony and an indication for ICD therapy who were successfully implanted with the InSync ICD. All patients received ICD therapy and were randomized to either the control group or to CRT therapy. Effectiveness endpoints were based on the randomized patients who completed a six-month follow up. Patients were required to be stabilized on heart failure medications before enrollment and maintain a stable heart failure regimen to assess the effects of cardiac resynchronization therapy on the study's objectives.

Results of the study showed that the InSync ICD system met or exceeded all safety objectives and demonstrated:

-- Improved Quality of Life assessment, as measured by the Minnesota Living
With Heart Failure Questionnaire;

-- Improved exercise capacity, as measured by cardiopulmonary exercise testing;


-- Improved functional status, as measured by the clinical composite response
that considered mortality, hospitalization for heart failure and worsening NYHA
heart failure classification.

"This study shows that the InSync ICD is safe and that it improves the quality of life and functional status of this patient population," said Dr. Young. "The bottom line is that this system, with both cardiac resynchronization therapy and VT/VF therapy, can offer heart failure patients better health and greater peace of mind."

Heart failure is the only major cardiovascular problem that is growing in prevalence, with more than 500,000 new cases diagnosed each year. The annual healthcare cost in the United States alone is estimated at nearly $40 billion. Worldwide, approximately 22 million people suffer from heart failure.

The InSync, InSync(R) III and InSync ICD cardiac resynchronization systems, along with several models of Attain left-heart leads and delivery tools, are commercially available outside the United States. The InSync system, including the Attain CS Model 2188, Attain LV Model 2187 left-heart leads and the Attain LDS and Access left-heart delivery systems, were approved for use in the United States in August 2001. The InSync ICD and InSync III devices, along with the Attain SD Model 4189 and Attain Over-the-Wire Model 4193 leads, are still 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 27, 2001. Actual results may differ materially from anticipated results.

NOTE TO EDITORS: Photo available on http://www.medtronic.com/newsroom/.