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Medtronic to Unveil Its Technological Advances in Atrial Fibrillation and Heart Failure to Nation's Cardiologists in Orlando.


Business Editors, Health/Medical Writers

ORLANDO, Fla.--(BUSINESS WIRE)--March 18, 2001

Multiple Therapeutic Options, Plus Innovative Technologies

and Products Address Significant Unmet Medical Needs

Many of the nation's cardiologists will hear for the first time this week about innovative new technological approaches from 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) →
), that may ultimately change their standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given  for heart failure and atrial fibrillation -- chronic diseases that affect millions of Americans.

Coinciding with the 50th annual scientific sessions of the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S.  (ACC See adaptive cruise control. ), leading physicians will unveil for their colleagues the results of a major study on a breakthrough Medtronic therapy for heart failure patients. Throughout the week, the company will brief physicians about progress in product advancements for this condition and for the treatment of dangerously fast 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.
 rhythms.

Pursuing multiple product platforms, Medtronic offers physicians and their patients the greatest variety of device-based options for managing atrial fibrillation, which is the world's most common heart problem. Medtronic received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval of the GEM III AT implantable cardioverter 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  (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.

ICD
abbr.
) on February 13, 2001. The GEM III AT ICD, a breakthrough product that offers the most comprehensive set of tools for managing both atrial and ventricular arrhythmias, provided significant momentum to the launch of the company's device-based atrial therapies into the U.S. marketplace.

"This week heralds a whole new era in therapeutic advances for patients suffering from atrial fibrillation and heart failure," says William W. George William W. George, author of National Best Sellers True North and Authentic Leadership, is professor of Management Practice at Harvard Business School,and former Chairman and Chief Executive Officer (CEO) of Medtronic. , Medtronic's chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Medtronic has been concentrating its research efforts on developing innovative solutions for heart failure and atrial fibrillation since 1993. Now the products are coming into commercial realization to offer meaningful new therapy options for patients suffering from these chronic diseases."

Progress on Heart Failure

Heart failure is the leading cause of death in the United States, afflicting more than 5 million Americans and 22 million people worldwide with varying degrees of severity. Related hospitalizations total more than 6.5 million days a year in the United States, with total costs of treating the disease estimated at more than $38-40 billion annually. In about a third of patients seriously ill with heart failure, their hearts exhibit major intraventricular electrical conduction delays that disturb the synchronous beating of the left and right ventricles reducing their ability to pump adequate blood to supply the body with necessary oxygen and nutrients.

The major news of this year's ACC meeting concerns the eagerly awaited announcement of results from Medtronic's MIRACLE (Multicenter InSync RAandomized CLinical Evaluation) trial of severely ill heart failure patients.

Data gathered from 44 centers in the U. S. and Canada will measure the therapeutic benefits of the Medtronic InSync(R)cardiac resynchronization system. The MIRACLE study will be discussed during the ACC's late-breaking clinical trials session on Tuesday, March 20, 2001, beginning at 8:45 a.m. EST EST electroshock therapy.

EST
abbr.
electroshock therapy
. William Abraham, M.D., University of Kentucky Coordinates:  The University of Kentucky, also referred to as UK, is a public, co-educational university located in Lexington, Kentucky.  Medical Center, and lead clinical investigator on the MIRACLE trial, will make the presentation. It will be followed by a Medtronic-hosted webcast, at noon EST, at http://www.medtronic.com/corporate/invest.html. George will participate, along with Steve Mahle, who heads Medtronic's 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.  business, Dr. Abraham, and Randy Lieberman, M.D., of Harper Hospital, Detroit.

On the heels of the MIRACLE presentation, the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world.  is expected to publish a paper on the results of last year's MUSTIC (MUltisite STImulation in Cardiomyopathy Cardiomyopathy Definition

Cardiomyopathy is a chronic disease of the heart muscle (myocardium), in which the muscle is abnormally enlarged, thickened, and/or stiffened.
) trial of cardiac resynchronization involving Medtronic's InSync system. The MUSTIC trial was sponsored by the European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe. , with financial and technical assistance from Medtronic, Inc., and ELA Noun 1. ELA - an extreme leftist terrorist group formed in Greece in 1971 to oppose the military junta that ruled Greece from 1967 to 1974; a revolutionary group opposed to capitalism and imperialism and the United States
Revolutionary People's Struggle
 (France). The European trial included a smaller number of heart failure patients and asked if ventricular resynchronization improved exercise tolerance and the quality of life. The paper is scheduled to appear in the March 22, 2001, issue of NEJM NEJM New England Journal of Medicine .

At ACC, Medtronic will present a broad portfolio of treatment options in various combinations tailored to the specific needs of multiple patient populations. For heart failure, Medtronic's systems include:
-- InSync, an atrial synchronous biventricular pacing system commercially
released in Europe in 1998. Medtronic recently filed its pre-market approval
(PMA) submission with the FDA for release in the United States. o InSync ICD,
which combines cardiac resynchronization therapy with the safety of a 30-joule
delivered output for those patients who require defibrillation capability. The
device was commercially released to the European market in June 2000 and
remains investigational in the United States.

-- InSync III, a third-generation cardiac resynchronization device with three
independent channels for sensing and pacing, plus programmable v-v delays and
other heart failure-specific diagnostic tools allowing for individualized
therapy. It is undergoing clinical evaluation worldwide.

-- Attain(R) portfolio of left-heart lead products, designed to meet each
patient's unique anatomical requirements. Some models are currently under
clinical evaluation. o Chronicle(TM) Patient Management System, which uses the
Internet to deliver to clinicians' offices the real-time data from the
implantable Chronicle hemodynamic monitor, an investigational device for
difficult-to-treat heart failure patients. The Chronicle system allows
continuous monitoring from home or other remote location of intracardiac
pressures, heart rate, core temperature and other clinical indicators to
facilitate precise drug titration.


Progress on Atrial Fibrillation

Atrial fibrillation is a too-rapid heart rhythm problem that is estimated to affect 5 million worldwide and 2.2 million in the United States. Once thought relatively benign, atrial fibrillation can cause severe symptoms, including sudden, intermittent and perplexing per·plex  
tr.v. per·plexed, per·plex·ing, per·plex·es
1. To confuse or trouble with uncertainty or doubt. See Synonyms at puzzle.

2. To make confusedly intricate; complicate.
 heart "palpitations." If left untreated, the condition can lead to a fivefold increase in the risk of stroke. Atrial fibrillation is typically treated with drugs that often do not work well, cause side effects, or become less effective over time. Atrial arrhythmia episodes may interrupt household duties, work schedules and other activities as victims are hospitalized for costly tests, corrective shocks, or other therapies to restore normal heart rhythms.

Medtronic implantable devices set a new standard of care by offering proprietary capabilities to treat people who have, or may develop multiple heart rhythm problems. Cardiologists in Orlando will see and learn about:

-- The next-generation of implantable defibrillators such as the

GEM(R) III AT, a breakthrough product that provides

customizable parameters for managing both atrial and

ventricular arrhythmias; and the Jewel(R) AF, the world's

first dual-chamber defibrillator to offer atrial arrhythmia

management capabilities.

-- Sophisticated pacemakers such as the Medtronic AT500(TM), with

monitoring capabilities and painless atrial therapy prevention

and termination algorithms; Vitatron's Selection(TM) line of

products, which offer continuous monitoring to help guide

atrial tachyarrhythmia tachyarrhythmia /tachy·ar·rhyth·mia/ (tak?e-ah-rith´me-ah) any disturbance of the heart rhythm in which the heart rate is abnormally increased.

tach·y·ar·rhyth·mi·a
n.
; and Vitatron's Clarity(TM) family,

offering atrial sensing that allows for better recognition of

changes in atrial rhythms and improved mode-switching. The

AT500 pacing system is commercially available in Europe and

Canada and under clinical investigation in the United States.

The GEM III AT, AT500 and Jewel AF offer Medtronic's proprietary AT(TM) Trio, a suite of arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of  management tools that help physicians know their patient's atrial tachyarrhythmia through monitoring algorithms, protect them from the clinical impact of atrial tachyarrhythmia, and restore sinus rhythm with appropriate termination algorithms.

"The achievement of an implantable device such as the GEM III AT defibrillator with its capabilities to treat both atrial and ventricular arrhythmias is representative of the Medtronic objective to put powerful new tools in the hands of physicians to address multiple diseases or complex combinations of arrhythmias," Mahle said.

Based in Minneapolis, MN, Medtronic, Inc., is the world's leading medical technology company, creating lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

For more information on Medtronic's atrial fibrillation news, go to www.newstream.com/cgi-bin/display_story.cgi?2354. This site will be available beginning Monday, March 19, 2001.

For more information on Medtronic's heart failure news, go to www.newstream.com/cgi-bin/display_story.cgi?2367. This site will be available beginning Tuesday, March 20, 2001.

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 the company's Annual Report and on Form 10-K for the year ended April 30, 2000. Actual results may differ materially from anticipated results.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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