St. Jude Medical Announces FDA Approval of Next Generation Internet-Based Data Management...

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Tue Jan 22, 2008 4:33pm EST

St. Jude Medical Announces FDA Approval of Next Generation Internet-Based Data Management System for Implantable Cardiac Devices

  Merlin .net Patient Care Network provides physicians with improved
                access to important patient device data
ST. PAUL, Minn.--(Business Wire)--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and
Drug Administration (FDA) approval of software and firmware updates to
the Merlin(TM).net Patient Care Network (PCN). The new Merlin.net PCN
2.5 will expand availability of the system nationwide and provide
physicians with improved options for remotely monitoring their
patients with the most commonly-used St. Jude Medical implantable
cardiac devices.

   The upgraded system includes enhancements to the Housecall
Plus(TM) transmitter which patients use to convey data from their
devices over phone lines to the central Merlin.net PCN data
repository. The new modifications offer improved ease of use for
patients and physicians, a simple, one-step procedure for data
transmission, expansion of services to include the entire U.S., and
the ability to accommodate patients with devices who travel out of the
U.S. by allowing them to transmit data from overseas.

   The U.S. Veterans Health Administration (VA) has been using
Merlin.net PCN since August 2007 (through its National ICD
Surveillance Program). Currently, 20 VA Medical Centers have enrolled
to provide remote monitoring service to veterans with St. Jude Medical
defibrillators. Several special enhancements have been made in
Merlin.net PCN to facilitate patient registration, transfer important
device data to the VA National ICD Surveillance Program Web site, and
electronically paste text-rich reports into the VA Computerized
Patient Records System.

   In addition, St. Jude Medical is the first and only cardiac rhythm
management company to satisfy the requirements established by the IHE
(Integrating the Healthcare Enterprise), which promotes the adoption
of standards for sharing healthcare information seamlessly across
clinical settings. Compliance with IHE standards supports the
compatibility of Merlin.net PCN with electronic health record (EHR)
systems. By designing in an open architecture, St. Jude Medical allows
clinics and physicians to utilize Merlin.net with their choice of EHR
system. Merlin.net PCN already has successfully integrated into major
EHR systems, including GEMMS, Lumedx and NextGen (through eMedApps),
and is expanding its integration with other systems.

   "The integration between GEMMS and Merlin.net PCN represents two
market leaders moving beyond just interfacing data. These two, strong
integrated products give users - in this case hospitals and clinics -
a seamless clinical workflow." says Rodger P. Pinto, Ph.D., chief
executive officer of GEMMS.

   "Remote management of patients with implanted devices is critical
to optimizing the value of these therapies," said Steve Compton, M.D.,
chief of electrophysiology at Alaska Heart Institute. "The ability to
merge information captured by the device into the patient's electronic
health record would ensure that we have a complete patient history
from which to make clinical decisions. This can improve the quality of
care and efficiency of patient management, especially for patients who
are seen at more than one facility."

   Merlin.net PCN is an Internet-based central repository for patient
device data that gives physicians immediate access to detailed
information about the performance of the patient's device, allowing
them to assess the patient and determine the level of care needed.
Patients with implantable cardiac devices use the Housecall Plus
transmitter to send data from their devices directly to Merlin.net PCN
from the comfort of their own homes. The system gives patients the
freedom to send data, and physicians the ability to review it (during
or outside of regular office hours), which may contribute to better
early detection and care for patients with abnormal heart rhythms.

   Merlin.net PCN provides storage for important data that is
captured in a patient's implantable cardiac device - from the implant
procedure, in-office follow-up visits and remote follow-up
transmissions. Transmitted data includes reports of any episodes of
irregular heart rhythms as well as a real time electrogram (EGM) which
shows the patient's heartbeat at the time of transmission. Data
transmitted to the central repository is available to physicians via a
secure log-in, and can also be integrated into existing patient
electronic health records (EHRs) to ensure a comprehensive patient
history is generated and accessible.

   "The enhancements to our Merlin.net PCN system will enable better
efficiency for both physicians and patients,"said Eric S. Fain,
president of the St. Jude Medical Cardiac Rhythm Management Division.
"Seamless integration of patient data into electronic medical records
is key to delivering and improving quality of care. We have developed
Merlin.net PCN to be compatible with existing EHR systems, so
physicians can use it with the clinic- and hospital-based systems they
already have in use."

   About Merlin.Net Patient Care Network (PCN)

   Implantable cardiac devices are designed to capture and record
vast amounts of information about device performance and patient heart
rhythms that is vital to patient care. Merlin.net PCN not only stores
this information for physician access, but also allows data to be sent
directly to a clinic's or hospital's EHR system so the data is
included in the patient's comprehensive personal health record. With
immediate access to patient information through the secure Merlin.net
PCN website, physicians can monitor and assess patient device data and
determine the level of care needed remotely.

   Merlin.net PCN supports all currently marketed Atlas(R) and
Epic(R) family implantable cardioverter defibrillators (ICDs) and
cardiac resynchronization therapy (CRT-D) device families in the U.S.
The Merlin.net system adheres to the patient privacy standards and
requirements for the electronic transmission of health information, as
set forth by the Health Insurance Portability and Accountability Act
of 1996 (HIPAA).

   About St. Jude Medical

   St. Jude Medical is dedicated to making life better for cardiac,
neurological and chronic pain patients worldwide through excellence in
medical device technology and services. The Company has five major
focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiac surgery, cardiology and neuromodulation.
Headquartered in St. Paul, Minn., St. Jude Medical employs
approximately 12,000 people worldwide. 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
Company's Annual Report on Form 10-K filed on February 28, 2007 (see
pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9,
2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The
Company does not intend to update these statements and undertakes no
duty to any person to provide any such update under any circumstance.

St. Jude Medical, Inc.
Investor Relations:
Angela Craig, 651-481-7789
or
Media Relations;
Kathleen Janasz, 651-415-7042

Copyright Business Wire 2008
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