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Medtronic Announces First Implant of InSync Marquis™ System, the Company's Fourth Generation Heart Failure Device

Medtronic Announces First Implant of InSync Marquis™ System, the Company's Fourth Generation Heart Failure Device

Medtronic GmbH

Medtronic today announced the first implant of the InSync Marquis™ system, the company’s fourth-generation heart failure device and its second to treat patients who also need the protection of an implantable defibrillator. The InSync Marquis Ÿ like the InSync® ICD that is currently in review by the U.S. Food and Drug Administration Ÿ provides cardiac resynchronization therapy (CRT) plus advanced defibrillation capabilities for patients at risk of potentially lethal tachyarrhythmias that may lead to sudden cardiac arrest.

The InSync Marquis device combines the cardiac resynchronization therapy of Medtronic’s InSync ICD, the heart failure diagnostics of InSync® III, and all of the advanced features of Medtronic’s Marquis™ DR implantable cardioverter-defibrillator. The Marquis DR ICD received FDA approval March 1, 2002, while the InSync III device is commercially released outside the United States. The InSync ICD system was recommended for approval by an advisory panel of the FDA on March 5, 2002.

The InSync Marquis was implanted in a 65-year old man by Dr. Thomas Schwierz at the Krankenhaus der Elisabethinen clinic in Linz, Austria, under the direction of heart failure specialist, Dr. Siegmund Winter. The patient had received a Medtronic MicroJewelÔ defibrillator in 1996 to treat ventricular arrhythmias resulting from a previous myocardial infarction and coronary artery disease. Over the last several years, he gradually developed progressive heart failure.

"The InSync Marquis system gives me confidence that my heart failure patients are well treated," said Dr. Winter. "The high defibrillation output and heart failure diagnostics are especially important for patients with this condition."

Additional implants of the InSync Marquis as part of clinical trials have also occurred in Sweden and Italy.

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

"Medtronic is the only medical device company helping patients with four generations of heart failure devices and five left ventricular leads – the broadest suite of resynchronization products available globally," said Mahle. "Clinical studies now clearly support the benefits of cardiac resynchronization therapy."

The InSync Marquis system is in clinical evaluation outside the United States 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.

Approximately 750,000 people in the United States may be candidates for cardiac resynchronization therapy. Of those, an estimated 100,000 or more are indicated for ICD therapy. Based on the Marquis DR platform, the InSync Marquis is 38 cc in size Ÿ the smallest on the market Ÿ with 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.

Many of the Marquis platform features are designed to help physicians manage patients more efficiently and quickly. RapidReadÔ telemetry offers up to 20 times improvement in telemetry speed and increased range, while LeadlessÔ ECG enables patients to spend less time in the clinic during the follow-up process. Cardiac CompassÔ helps physicians monitor cardiac disease progression for more effective treatment.

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® CRT system, available globally since August 2001 and the only cardiac resynchronization system on the market in the U.S., and InSync III, which is currently under review in the United States.

Global market release of the InSync Marquis device is expected in the fall of 2002.

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. The annual healthcare cost in the United States alone is estimated at $40 billion.

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 .


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