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FDA Approves V-V Timing Feature for Medtronic InSync Sentry and InSync Maximo Systems.


MINNEAPOLIS -- Sequential biventricular pacing facilitates precise adjustment of ventricular heartbeat

Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT) today announced it received approval by the U.S. Food and Drug Administration (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.
) to add sequential biventricular pacing or "V-V (ventricle to ventricle) timing" to its InSync Sentry(TM) and InSync Maximo(TM) cardiac resynchronization therapy defibrillators (CRT-Ds). V-V timing allows physicians to separately adjust the timing of electrical therapy delivered to the heart failure patient's two ventricles, which can optimize the beating of the heart and enhance the flow of blood throughout the body.

Starting in the next two weeks, shipped InSync Sentry and InSync Maximo devices will include V-V timing. In addition, special software will be released to allow patients who already have a previous model of these devices to benefit from the feature through a simple, in-clinic software programming change.

In addition, FDA approved a labeling modification for InSync Sentry and InSync Maximo systems to include use for heart failure patients who have prolonged QRS QRS
A pattern seen in an electrocardiogram that indicates the pulses in a heart beat and their duration. Variations from a normal QRS pattern indicate heart disease.

Mentioned in: Bundle Branch Block
 duration.

"Adjustment of ventricle timing can be especially beneficial when patients need every bit of pumping power," said William Abraham, M.D., chief of cardiology at The Ohio State University Ohio State University, main campus at Columbus; land-grant and state supported; coeducational; chartered 1870, opened 1873 as Ohio Agricultural and Mechanical College, renamed 1878. There are also campuses at Lima, Mansfield, Marion, and Newark. . "This advantage will be significant for many patients, including those who already have a Medtronic InSync Sentry or InSync Maximo, since they won't need to undergo another implant to take advantage of this important benefit."

At the Heart Rhythm Society Annual Scientific Sessions on May 6, Dr. Abraham will present clinical data about patient response to V-V timing in the InSync III Marquis(TM) clinical trial, a Medtronic-sponsored randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind controlled study evaluating the safety and effectiveness of sequential biventricular pacing.

"Medtronic is improving the management of heart failure with continual advancements like sequential biventricular pacing and breakthrough products like InSync Sentry," said Steve Mahle, 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.  president. "Our aim is to help patients experience a better quality of life while also helping physicians and hospitals contain healthcare costs."

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.
 resynchronizes the contractions of the heart's ventricles by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently and reduce heart failure symptoms. The 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.
 capability applies electrical impulses to stop potentially lethal heart rhythms. According to the American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities.
, patients with heart failure are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population.

Medtronic CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators  systems are the most widely implanted CRT-D systems in the world, and the company's CRT-D product portfolio includes devices with the longest battery life available and unique features not available in competitive devices. For example, the InSync Sentry system is the world's first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity, the chest area encompassing the lungs and heart. This advance is expected to provide a critical advantage in managing heart failure, since thoracic fluid accumulation is a primary indicator of worsening heart failure and often results in patient hospitalization.

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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 18, 2005
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