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Medtronic Announces U.S. FDA Approval of New Defibrillation Leads for Patients at Risk of Sudden Cardiac Arrest, the Nation's No. 1 Killer.


MINNEAPOLIS -- Sprint Fidelis(TM) family offers world's smallest 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.
 leads

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) →
), the leader in implantable medical devices such as pacemakers and defibrillators, today announced the U.S. Food and Drug Administration approval of the Sprint Fidelis(TM) family of defibrillation leads. Leads are thin insulated wires that connect an implantable cardioverter-defibrillator Implantable Cardioverter-Defibrillator Definition

The implantable cardioverter-defibrillator is an electronic device to treat life-threatening heartbeat irregularities. It is surgically implanted.
 (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.

ICD
abbr.
) directly to the heart and provide therapy for potentially lethal heart rhythms in patients at risk of 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.
, the nation's No. 1 killer.

At 6.6 French in size, Sprint Fidelis leads are the world's smallest right ventricular defibrillation leads, allowing for compatibility with 7 French introducers. An introducer is the instrument by which a physician inserts a lead into the chamber of the heart where therapy is typically delivered.

The small size of the Sprint Fidelis (Fidelis is a Latin word that means "faithful") helps improve passage into a patient's venous system for an easier implant, and minimizes venous obstruction.

"ICD leads tend to be heavy and more difficult to implant than pacemaker leads, but the Sprint Fidelis behaves and handles virtually identical to a pacemaker lead," said Raymond Yee, M.D., London Health Sciences Center, London, Ontario, who performed the first implant. "This makes doing an ICD implant a smoother, less arduous experience."

The Sprint Fidelis family comes in four models and will complement the Medtronic Sprint Quattro(TM) lead family, which are the industry's most implanted defibrillation leads. Sprint Fidelis leads will be available in both quadripolar and tripolar configurations, with active and passive fixation options.

Market release of these state-of-the-art leads is immediate in the United States. The Sprint Fidelis also has received CE mark in Europe and is nearing market release.

Approximately 3 million people worldwide have hearts that beat too fast. Abnormally rapid heartbeats can deteriorate into a life-threatening condition called ventricular fibrillation ventricular fibrillation

Uncoordinated contraction of the muscle fibres of the heart's ventricles (see arrhythmia). Causes include heart attack, electric shock, anoxia, abnormally high potassium or low calcium in the blood, and digitalis or epinephrine poisoning (
, the major cause of sudden cardiac arrest (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. ). Sudden cardiac arrest kills 450,000 Americans 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, AIDS and stroke combined. However, ICDs have been proven to be 98 percent effective in treating the rapid rhythms that lead to sudden cardiac arrest, and rapid defibrillation is the only effective treatment for this condition.

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 30, 2004. Actual results may differ materially from anticipated results.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 2, 2004
Words:438
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