St. Jude Medical Announces European Approval of ICDs with Features That Automatically Enhance Patient Safety and Streamline Patient Follow-up

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Mon Apr 20, 2009 4:05pm EDT

St. Jude Medical Accel family of devices provide new alerts and insight into
cardiac conditions such as atrial fibrillation and ischemia 
ST. PAUL, Minn.--(Business Wire)--
St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval of
its AnalyST Accel and Current Accel ICDs (implantable cardioverter
defibrillators), which automatically adjust therapy to changing patient needs
for increased safety and accelerated follow-up. 

The St. Jude Medical Accel family of ICD devices can be programmed to
automatically monitor and adjust the level of electrical energy needed for
stimulating the patient`s heart, which helps to ensure that adequate therapy is
consistently administered while conserving battery life. The devices do this by
measuring the heart`s reaction to electrical stimulation from the device and
confirming that the heart is responding to the stimulation. This AutoCapture
Pacing System feature provides the dual benefit of added safety for the patient
and added efficiency for physicians, as vital threshold tests are performed
automatically and results are available to the physician for review on demand
during follow-up via a simple device interrogation. In the St. Jude Medical
Accel family of ICDs, automatic threshold management is available on all leads
for the first time. 

To better assist physicians in accurately diagnosing and managing patients with
fast rates in the heart`s upper chambers (atria), the devices also include a new
AT/AF Alert feature. This feature is designed to notify physicians when a rapid
atrial rate (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a
programmed value or occurs over an extended time period. The devices can be
programmed to notify the patient through a unique vibratory alert that has been
proven more effective than audible alerts.1 Additionally, the devices have the
ability to inform the patient`s clinic through the St. Jude Medical Merlin@home
transmitter and Merlin.net Patient Care Network (PCN). These features allow the
physician to better manage patients` atrial arrhythmias, such as AF, with
appropriate medication or ablation. 

AF is the most common abnormal heart rhythm condition, affecting millions of
patients worldwide. With AF, the heart`s upper chambers (the atria) do not beat
effectively due to abnormal electrical activity. As a result, the heart cannot
effectively pump blood, which can lead to shortness of breath, heart
palpitations and fatigue. If left untreated, AF increases the risk of stroke
five-fold, according to a study reported in the journal Stroke (Wolf et al.,
Atrial Fibrillation as an Independent Risk Factor for Stroke: the Framingham
Study, 1991). 

"This family of devices enables me to streamline patient follow-up, allowing me
to better manage therapy," said Johannes Sperzel, M.D., of the Kerckhoff-Klinik
in Bad Nauheim, Germany. "The fact that these tests are performed and thresholds
are adjusted automatically means that I can quickly assess the results and then
focus on other matters that concern the patient." 

In addition, the AnalyST Accel ICD includes the company`s proprietary ST
Monitoring diagnostic algorithm, which continuously monitors specific changes in
the heart`s electrical system. These changes can indicate conditions such as
ischemia (which occurs when blood flow/oxygen to the heart muscle is
obstructed). With the ST Monitoring diagnostic algorithm, small changes in the
ST segment are continuously recorded and plotted; the information can then be
retrieved by the physician via the Merlin Patient Care System during in-office
follow-up. Alerts can also be configured so information about ST segment changes
is sent directly to the physician through DirectAlerts notification, available
with the Merlin.net PCN and the Merlin@home patient transmitter. Because many
cardiac episodes are transient in nature, the continuous ST Monitoring
capability available in the AnalyST Accel ICD gives physicians more
comprehensive information over time compared to the standard electrocardiogram
(ECG). This can add important and never-before-available information to assist
in medical decision making and accelerate patient care. 

"Our goal in providing automaticity for vital tests is to enhance patient safety
by providing physicians the tools to optimize therapy delivery," said Eric S.
Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management
Division. "Because the tests are performed on an ongoing basis, adjustments can
be made if necessary. Furthermore, the results and other patient information can
be accessed in the office or over the telephone via remote monitoring, ensuring
that access to information about the patient`s condition is readily available." 

The St. Jude Medical Accel family of products also includes other features
available in the company`s ICDs, such as:

* QuickOpt Timing Cycle Optimization - A programmer-based optimization method
for people with cardiac resynchronization therapy defibrillators (CRT-Ds) and
ICDs that helps physicians quickly - in less than 90 seconds - program a
device's timing cycles to help deliver optimal therapy to patients. As
demonstrated in clinical studies, the QuickOpt feature produces results that are
comparable to echocardiography, the current gold standard, but is significantly
less costly and time-consuming. 
* DeFT Response technology - which is designed to help devices meet the needs of
patients who may have high or varying thresholds for the amount of energy
required to defibrillate the heart. This enables the physician to tailor device
therapy for individual patients, offering them added protection in the event of
a life-threatening arrhythmia. 
* SenseAbility technology - which is designed to optimize sensing to help
protect against inappropriate shocks.

An ICD is a small device implanted in the chest to treat potentially lethal,
abnormally fast heart rhythms (ventricular tachycardias or ventricular
fibrillation), which often lead to sudden cardiac death (SCD). An ICD delivers
potentially life-saving therapy from the device to the patient's heart through
an insulated wire or lead. 

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting
more control into the hands of those who treat cardiac, neurological and chronic
pain patients worldwide. The company is dedicated to advancing the practice of
medicine by reducing risk wherever possible and contributing to successful
outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical
employs approximately 14,000 people worldwide and has five major focus areas
that include: cardiac rhythm management, atrial fibrillation, cardiac surgery,
cardiology and neuromodulation. For more information, please visit www.sjm.com. 

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. Such forward-looking statements include the expectations, plans
and prospects for the Company, including potential clinical successes,
anticipated regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by the
Company are based upon management`s current expectations and are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include market conditions and other factors beyond the
Company`s control and the risk factors and other cautionary statements described
in the Company`s filings with the SEC, including those described in the Risk
Factors and Cautionary Statements sections of the Company`s Annual Report on
Form 10-K for the fiscal year ended January 3, 2009. The Company does not intend
to update these statements and undertakes no duty to any person to provide any
such update under any circumstance. 

1 Bennett MT et al. "The ICD patient alert is potentially an unreliable ICD
warning feature." Presented at the Canadian Cardiovascular Congress, Toronto,
Ontario, October 26, 2008. 



St. Jude Medical, Inc.
www.sjm.com
Angela Craig, 651-481-7789
Investor Relations
acraig@sjm.com
or
Amy Jo Meyer, 651-766-3029
Media Relations
ameyer@sjm.com

Copyright Business Wire 2009

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