Medtronic Applauds Expanded ACC/AHA/NASPE Guidelines as Life-Saving and Life-Changing Opportunities for Hundreds of Thousands of Heart Failure and Heart Attack Patients.

Business Editors & Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--Sept. 25, 2002

New Guidelines Include Categories for Cardiac Resynchronization

Therapy and MADIT II Indication

Medtronic (NYSE:MDT) today announced its support for the expanded guidelines issued by the American College of Cardiology (ACC), American Heart Association (AHA) and North American Society of Pacing and Electrophysiology (NASPE) as life-changing and life-saving opportunities for the hundreds of thousands of patients who suffer from heart failure and/or are at risk of sudden cardiac arrest following heart attacks.

The ACC/AHA/NASPE guidelines, revised for the first time since 1998, include a first-ever cardiac resynchronization therapy guideline for heart failure patients, and add an additional defibrillator guideline based on the MADIT II clinical study for a group of patients who have survived heart attacks. Both are listed as Class IIa guidelines, and could eventually affect up to 1 million people in the United States between the two patient groups.

"We heartily applaud these organizations for their diligent work in reviewing the mounting body of clinical evidence and then acting to expand the guidelines to protect eligible heart failure patients, as well as heart attack survivors who are at risk for sudden cardiac arrest and could be protected with an implantable defibrillator," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "These new guidelines will result in thousands of additional lives being saved, and a better quality of life for thousands more."

A Class IIa guideline is defined as a condition for which the "weight of evidence/opinion is in favor of usefulness/efficacy" about a procedure or therapy. There are currently five separate Class I indications for implantable cardioverter-defibrillators (ICDs) and several Class II indications.

"Essentially, what this means is that thousands of additional people now have the opportunity to benefit from these two therapies," said Marshall Stanton, M.D., Medtronic CRM medical director. "These should become the standards of care for patients who meet the criteria. Much of the guesswork has been removed in making therapy decisions for these patients."

Inclusion of MADIT II in the guidelines is based on a clinical study that showed a 31-percent reduction in mortality for certain heart attack patients who receive ICD therapy, compared to those who received conventional medical treatment. Under the new indication, these patients no longer have to undergo an invasive electrophysiology study before receiving an implantable defibrillator. It is estimated that this could affect up to 300,000 additional patients who are at risk for sudden cardiac arrest following recovery from a myocardial infarction (heart attack).

For heart failure patients, cardiac resynchronization therapy (CRT) was introduced in the United States in August 2001 when the Food and Drug Administration approved the Medtronic InSync(R) cardiac resynchronization system. The FDA also approved Medtronic's InSync(R) ICD system in June 2002, providing a therapeutic option for patients who need the protection of an ICD as well as cardiac resynchronization therapy, which is also known as bi-ventricular pacing. Cardiac resynchronization therapy was further validated in June of this year when data from the MIRACLE clinical trial were published in the prestigious New England Journal of Medicine.

Medtronic offers the broadest suite of state-of-the-art products for both heart failure and tachyarrhythmia patients who have weakened hearts. It is the only company to offer CRT devices to two distinct patient populations in the United States. Of the 5 million Americans afflicted with heart failure, an estimated 750,000 could benefit from cardiac resynchronization therapy and, of those, approximately 100,000 or more are indicated for an implantable defibrillator. The Medtronic Marquis(TM) DR ICD, approved by the FDA in March 2002, is the world's most implanted defibrillator, while the InSync CRT system has become the world standard for CRT systems.

ICDs are about the size of a small stopwatch. They incorporate the technology of external defibrillators used in hospital emergency rooms across the country and are implanted under the skin in the shoulder area. Once in place, the ICD constantly monitors the heart's rhythm and automatically delivers the appropriate therapy to interrupt a life-threatening arrhythmia and restore a normal heartbeat. Each year, approximately 450,000 people die from sudden cardiac arrest 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 Medtronic's Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.