Merlin@home transmitter automatically monitors patients with
implantable cardiac devices and alerts physicians if patients or
devices require attention
ST. PAUL, Minn.--(BUSINESS WIRE)--July 15, 2008--St. Jude Medical,
Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration
(FDA) approval of the Merlin(TM)@home transmitter, an RF wireless
technology that remotely monitors patients' implanted cardiac devices.
The transmitter supports the St. Jude Medical Current(R) RF and
Promote(R) RF family of devices and works in conjunction with the St.
Jude Medical data management system, Merlin(TM).net Patient Care
Network (PCN), to provide complete remote care service for patients
and their physicians.
Until recently, patients with implanted cardiac devices were
typically required to visit doctors' offices several times per year to
have their device performance checked. With the advent of transmitters
capable of downloading and transmitting device data over telephone
lines, patients are now able to initiate and perform many of these
follow-ups in their own homes.
The Merlin@home transmitter's wireless technology gives patients
the additional comfort of having devices automatically checked. Since
the transmitter initiates the scheduled follow-up and uses RF wireless
telemetry to download data from the device, the entire follow-up
procedure is conducted without any direct patient involvement. The
only requirement is that each patient remains within range of the
transmitter while it reads his or her device. Patients also may
initiate data transmissions as instructed by their physicians.
The Merlin@home transmitter is transportable and can be set-up
wherever a standard phone line is available, typically by the bedside
for data transmission while the patient sleeps. Data downloaded by the
Merlin@home transmitter is sent to Merlin.net PCN, a secure,
Internet-based data management system, where it is stored for review
by the patient's physician.
"We have simplified remote follow-ups to the extent that they are
now something that can be performed seamlessly without interrupting
the patient's day. Patients simply set-up the Merlin@home transmitter;
after that, the system handles all aspects of patient follow up,
including daily monitoring," said Eric S. Fain, M.D., president of the
St. Jude Medical Cardiac Rhythm Management Division. "The simplicity
of the system reduces the chance of patients missing follow-up
The Merlin@home transmitter also monitors cardiac devices outside
of regularly scheduled follow-ups. The system can perform daily checks
to monitor for alerts about device performance or about patient heart
rhythms that may have been detected by the implanted device.
Merlin.net PCN can be programmed to alert a physician directly -
including an on-call physician outside normal business hours - in the
event that the monitored data reveals an episode the physician needs
to know about as soon as possible.
"By directly alerting physicians, the Merlin@home transmitter and
Merlin.net PCN can help reduce risks associated with cardiac episodes
that physicians would want to know about right away," said Fain.
"Without this notification, these events might go undetected for
significant amounts of time. Direct notification is one more way to
give physicians more control over their patient's critical health
The Merlin@home transmitter will be available in the U.S. early
this fall and internationally in the fourth quarter.
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 physicians to review, but also allows data to be
sent directly to a clinic's or a hospital's electronic health records
(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 remotely
monitor and assess patient device data and determine the level of care
needed. Alert notification delivery times can be customized by the
Other Merlin.net PCN features include DirectCall(TM) Message,
which uses an interactive voice recognition (IVR) system to call
patients to remind them of upcoming scheduled follow-ups, inform them
if they have missed a follow-up, confirm that their transmitted data
has been reviewed or ask them to call their physician's office for
Merlin.net PCN supports all currently marketed Atlas(R) and
Epic(R) implantable cardioverter defibrillators (ICDs) and cardiac
resynchronization therapy (CRT-D) devices in the U.S, as well as
Current(R) RF and Promote(R) RF devices. The Merlin.net PCN system
adheres to 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 and Connectivity
St. Jude Medical is the only cardiac rhythm management company
able to transfer information directly from the remote care system to a
patient's electronic health record using the requirements established
by the IHE (Integrating the Healthcare Enterprise), which promotes
standards for securely sharing healthcare information across clinical
settings. Meeting these standards helps make the transfer of patient
data from Merlin.net PCN to the clinic's electronic health record
(EHR) system seamless and secure.
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
more than 12,500 people worldwide and has five major focus areas that
include: cardiac rhythm management, atrial fibrillation, cardiac
surgery, cardiology and neuromodulation. For more information, please
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 filed on February 27, 2008. The Company does not
intend to update these statements and undertakes no duty to any person
to provide any such update under any circumstance.
CONTACT: St. Jude Medical, Inc.
Angela Craig, 651-481-7789
Kathleen Janasz, 651-415-7042
SOURCE: St. Jude Medical, Inc.