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FDA Approves Medtronic CardioSight Service; Heart Failure Physicians Gain Access to Key Heart Failure and Heart Rhythm Data.


MINNEAPOLIS -- Access to OptiVol(TM) Fluid Status Monitoring and Other Data Facilitates Immediate Treatment Decisions to Potentially Reduce Hospitalizations

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 of its CardioSight(TM) Service, an in-clinic data access tool now available to physicians treating heart failure patients who have one of several Medtronic cardiac resynchronization therapy defibrillators (CRT-Ds) or implantable cardioverter-defibrillators (ICDs).

CardioSight Service provides clinically valuable, device-derived information applicable to the treatment of heart failure to help specialty physicians discern if the heart failure patient's symptoms are stable or deteriorating. For example, heart failure physicians following patients with a Medtronic InSync Sentry(TM) CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators  system can use CardioSight Service to track patient fluid levels in the thoracic cavity thoracic cavity
 or chest cavity

Second largest hollow space of the body, enclosed by the ribs, vertebral column, and breastbone and separated from the abdominal cavity by the diaphragm.
 (chest and lungs) through the implantable device's innovative OptiVol(TM) Fluid Status Monitoring feature. By identifying and addressing heart failure symptoms more rapidly and effectively, physicians using the CardioSight Service may help prevent emergency treatment or hospitalizations.

"Currently, it's very challenging for heart failure physicians to reliably, efficiently and regularly monitor their patients' heart rhythm Noun 1. heart rhythm - the rhythm of a beating heart
cardiac rhythm

regular recurrence, rhythm - recurring at regular intervals

atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the
 activity or lung fluid levels," said Randall C. Starling starling, any of a group of originally Old World birds that have become distributed worldwide. Starlings were brought to New York in 1890; since then the common starling (Sturnus vulgaris) has spread throughout North America. , M.D., head, Section of Heart Failure and Cardiac Transplant Medicine Department of Cardiovascular Medicine, Cleveland Clinic Cleveland Clinic (formally known as the Cleveland Clinic Foundation) is a multispecialty academic medical center located in Cleveland, Ohio, USA. Cleveland Clinic was established in 1921 by four physicians for the purpose of providing patient care, research, and medical  Foundation. "Symptom-driven, immediate access to this data will aid the heart failure team to optimize diagnosis and management of these symptoms. Information from CardioSight Service may enable us to pinpoint the reason for the patient's symptoms and provide effective treatment for heart failure patients with implanted devices."

CardioSight Service is a non-invasive, device information access system for in-clinic use by physicians who regularly care for heart failure patients with an implanted Medtronic device, but did not implant the cardiac device. It provides simple and timely access to information about a patient's physiological condition Noun 1. physiological condition - the condition or state of the body or bodily functions
physical condition, physiological state

wakefulness - a periodic state during which you are conscious and aware of the world; "consciousness during wakefulness in a sane
 that previously was unavailable to physicians who don't implant devices or have access to a device programmer. This information would not be otherwise readily available to the physician without a formal evaluation of the device at a cardiology clinic.

At the touch of a button, data can be transmitted from the implantable device via the CardioSight(TM) Reader. By holding the Reader's antenna (similar size and shape of a computer mouse) over the implantable device, the physician can quickly collect and download 90 days of the patient's cardiac rhythm trends and patient activity patterns without a device programmer. A report of this information is available by fax within minutes after the data is collected.

"The ability to diagnose and manage changes in heart rhythm patterns and heart failure symptoms is an important innovation we believe will improve standards of patient care," 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. . "Our devices can monitor and detect a wealth of clinical information, such as fluid buildup in the thoracic cavity with our new InSync Sentry system. By pairing these implantable devices with innovative information access solutions like CardioSight Service, we can help more physicians identify changes in a patient's condition and modify prescribed therapies, which in turn may reduce hospitalizations."

Reports generated by the CardioSight Service will give heart failure physicians an improved ability to:

--Track intrathoracic fluid accumulation via OptiVol Fluid Status Monitoring that monitors fluid build-up in a patient's chest and lungs;

--Corroborate patient symptoms;

--Identify asymptomatic arrhythmias;

--Evaluate the efficacy 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  treatments; and

--Titrate drug dosages.

Afflicting af·flict  
tr.v. af·flict·ed, af·flict·ing, af·flicts
To inflict grievous physical or mental suffering on.



[Middle English afflighten, from afflight,
 five million Americans, heart failure is the leading cause of U.S. hospital admissions, with most due to fluid accumulation in the thoracic cavity. It is estimated that heart failure is responsible for $40 billion in direct and indirect healthcare costs in this country alone. The number of Americans with heart failure is expected to double in the next five years as the "Baby Boomer" population ages.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended April 29, 2005. 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:Aug 17, 2005
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