Medtronic Announces FDA Approval Of InSync Marquis™ Cardiac Resynchronization Therapy System

MINNEAPOLIS, March 28, 2003 – Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration approval of the InSync Marquis™ cardiac resynchronization therapy system, the smallest, lightest FDA-approved device of its type, with features that help physicians provide improved patient management. Like the industry-leading InSync ICD® system, the InSync Marquis device provides cardiac resynchronization therapy (CRT) plus advanced defibrillation capabilities for patients at risk of potentially lethal tachyarrhythmias that may lead to sudden cardiac arrest.

With the exclusive Cardiac Compass™ trend feature, the InSync Marquis system provides physicians with important heart failure information, enabling doctors to monitor disease progression for up to 14 months. Many of its other functions also are designed to help physicians manage patients more efficiently and quickly. RapidRead™ telemetry offers up to 20 times improvement in device interrogation speed for quicker follow-up sessions, while Leadless™ ECG enables patients to spend less time in the clinic during the follow-up process without disrobing.

At just 38 cc in size and 77 grams in weight, the InSync Marquis device combines the heart failure diagnostics and patient monitoring capabilities of the InSync® III system, plus all of the advanced features of Medtronic’s Marquis™ DR implantable cardioverter-defibrillator, the world’s most implanted ICD. The Marquis DR ICD received FDA approval March 1, 2002, while the InSync III device was approved on Feb. 25, 2003.

The InSync Marquis system is Medtronic’s fourth heart failure system approved in the United States in the past 20 months and its second to treat patients who also need the protection of an implantable defibrillator. The InSync ICD device has been available in the United States since June 2002.

Steve Mahle, president of Medtronic’s Cardiac Rhythm Management division, noted that the company continues to expand its portfolio of heart failure products, with new devices, left-heart leads and delivery systems that offer physicians the widest variety of choices for managing their heart failure patients.

“Clinical studies clearly support the benefits of ICDs for patients at risk of ventricular arrhythmias, and cardiac resynchronization therapy for patients with moderate to severe heart failure,” said Mahle. “InSync Marquis is a highly advanced system that provides the best possible management and treatment of each of these conditions.”

Based on the Marquis DR platform, the InSync Marquis device features 30 joules of delivered energy, and charge times of less than 7.5 seconds throughout the service life of the device. Charge time is the time needed before an implantable device delivers life-saving defibrillation therapy once an abnormally fast heart rhythm is detected.

In addition to the InSync ICD and InSync Marquis devices, Medtronic also has two products that offer cardiac resynchronization therapy for patients who are not indicated for a defibrillator. They are the InSync® cardiac resynchronization system, available globally since August 2001, and the InSync® III system approved last month. Those two devices are the only cardiac resynchronization systems on the market in the U.S. for this patient population, and InSync III is the only system available in the U.S. with sequential bi-ventricular pacing. This function allows physicians to adjust the pacing sequence of the two lower heart chambers to improve cardiac performance.

Heart failure is the only major cardiac disease that continues to grow in prevalence. One of the most debilitating and costly of all heart diseases, it affects an estimated 5 million persons in the United States and more than 22 million worldwide. Approximately 750,000 people in the United States may be candidates for cardiac resynchronization therapy. Of those, an estimated 100,000 or more also are indicated for ICD therapy. The annual healthcare cost for heart failure in the United States is estimated at $40 billion.

The InSync Marquis system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias, and who have moderate to severe heart failure with ventricular dysynchrony. The implantable cardioverter-defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. ICDs are stopwatch-sized devices that continually monitor the heart and deliver appropriate therapy when an abnormal heart rhythm is detected. They have been proven to be 99 percent effective in treating dangerous ventricular arrhythmias.

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.