Medtronic Announces FDA Approval of EnRhythm Pacemaker; Dual-Chamber Pacemaker Significantly Reduces Unnecessary Pacing in the Right Ventricle.MINNEAPOLIS -- 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 the U.S. Food and Drug Administration approval and U.S. launch of the dual-chamber EnRhythm(TM) pacemaker, which promotes natural heart activity by significantly reducing unnecessary pacing in the heart's right ventricle right ventricle n. The chamber on the right side of the heart that receives venous blood from the right atrium and forces it into the pulmonary artery. (lower chamber). Clinical studies have shown that unnecessary pacing in the right ventricle can increase the risk for heart failure and atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. . The EnRhythm device is the first-ever pacemaker to offer an exclusive pacing mode called MVP (Multimedia Video Processor) A high-speed DSP chip from Texas Instruments, introduced in 1994. Officially introduced as the TMS320C80, it combines RISC technology with the functionality of four DSPs on one chip. (TM) or Managed Ventricular Pacing, which enables the device to be programmed to deliver pacing pulses to the right ventricle less than 2 percent of the time. Other dual-chamber pacemakers often pace the right ventricle 90 percent or more of the time. Medtronic first introduced MVP in its Intrinsic(TM) implantable cardioverter-defibrillator in 2004. "Since dual-chamber pacemakers were introduced in the early 1980s, the devices typically delivered pacing therapy to the right ventricle. We now have an option that is better for the heart," said Michael O. Sweeney, M.D., electrophysiologist at Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. in Boston and the principal investigator for the MVP clinical trials. "The ability of the EnRhythm device with MVP to intuitively prohibit unnecessary right ventricular pacing is a landmark development in a new era of physiologic pacing." The EnRhythm pacemaker also offers Atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium. a·tri·al adj. Of or relating to an atrium. Atrial Having to do with the upper chambers of the heart. Reactive 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. (TM) (anti-tachycardia pacing), a feature enabling the device to continually search for opportunities to restore a patient's normal sinus rhythm during long, fast heart rhythm episodes in the atrium. Additionally, enhanced diagnostics provide comprehensive information to help assist physicians in the diagnosis of additional types of heart rhythm problems, especially in the atrium. "With nearly 1 million pacemakers implanted each year throughout the world, the patient benefits from this sophisticated device will reach many people. By applying recent scientific research, Medtronic is providing physicians with tools to help them tailor patient therapy so that patients only receive pacing therapy when and where necessary," said Steve Mahle, president of 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. . "This approach represents an important new direction in pacing that we expect will improve patient care and potentially prevent disease progression." The new EnRhythm device is one element of Medtronic's Physiologic Pacing Program, a comprehensive initiative focused on providing tailored solutions to promote or mimic a patient's normal cardiac function. 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 forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 30, 2004. Actual results may differ materially from anticipated results. |
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