Medtronic Receives FDA Approval for the InSync Maximo Cardiac Resynchronization Therapy Defibrillator.MINNEAPOLIS -- High energy, quick charge times help offer increased safety in treating sudden cardiac arrest cardiac arrest n. Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation. Cardiac arrest A condition in which the heart stops functioning. for heart failure patients Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) today announced U.S. Food and Drug Administration approval and commercial release of the InSync Maximo(TM) cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library. (2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons. ) defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a system, expanding the company's broad portfolio of industry-leading medical devices to treat heart failure. The InSync Maximo (TM) device incorporates proven cardiac resynchronization therapy to treat heart failure and the capacity to deliver high-output defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. energy to stop a lethally fast heart rhythm. With 35 joules of delivered energy and the industry's fastest charge times, InSync Maximo provides the highest margin of safety in treating sudden cardiac arrest. Charge time is the number of seconds between the time the device detects an abnormally fast rhythm fast rhythm n. A brain-wave pattern on an electroencephalogram that occurs at a frequency above 13 hertz. in the heart's lower chambers and the moment it is ready to deliver a life-saving defibrillation therapy. The sooner therapy is delivered, the higher the probability of a successful, life-saving defibrillation. "The InSync Maximo is a good example of a device that reflects Medtronic's mission of working with physicians to develop products that help increase safety for their patients and deliver more value to the health care community," said Steve Mahle, president, Medtronic Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. . "More and more, defibrillators offering 35 joules have become accepted by doctors, and many are adopting it as standard therapy for patients at risk of sudden cardiac arrest. There are 35-joule devices available from other companies, but none that can match the combination of power, charge time, size and longevity that patients will experience throughout the life of the InSync Maximo." Implantable defibrillation technology has been proven to be more than 98 percent effective in treating potentially lethal heart rhythms that can lead to sudden cardiac arrest. Sudden cardiac arrest kills approximately 450,000 people in the United States each year, more than lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. , breast cancer, stroke and AIDS combined. Like most recent Medtronic implantable defibrillators, the InSync Maximo system offers unique anti-tachycardia pacing (ATP ATP: see adenosine triphosphate. ATP in full adenosine triphosphate Organic compound, substrate in many enzyme-catalyzed reactions (see catalysis) in the cells of animals, plants, and microorganisms. ) options for pain-free termination of life-threatening fast ventricular tachyarrhythmias. Clinical studies have shown that Medtronic's sophisticated anti-tachycardia pacing function can dramatically reduce shocks for treating ventricular arrhythmias - a significant patient benefit - by as much as 77 percent. Heart failure is a chronic, progressive condition that occurs when the heart has become damaged and gradually loses its ability to pump enough blood to meet the body's needs. Cardiac resynchronization therapy helps re-coordinate the beating of the heart, often with dramatic quality of life improvements for many patients with moderate to severe heart failure. Studies have indicated that heart failure patients sometimes require more energy to terminate life-threatening arrhythmias and that their defibrillation thresholds also may rise over time. In addition, people suffering from heart failure are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population. 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 25, 2003. Actual results may differ materially from anticipated results. |
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