Products represent important next step in health care connectivity with the introduction of the first pacemaker devices with automatic test results and complete diagnostics that can be accessed via wireless communication in a clinic or remotely
ST. PAUL, Minn.--(BUSINESS WIRE)--Jul. 21, 2009--
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug
Administration (FDA) approval of its Accent™
RF pacemaker and Anthem™
RF CRT-P (cardiac resynchronization therapy pacemaker). The company
also announced FDA and European CE Mark approval of version 4.0 of the Merlin.net®
Patient Care Network (PCN), which supports the Accent RF and Anthem
The Accent and Anthem product family features RF telemetry that enables
secure, wireless communication between the implanted device and the
programmer used by the clinician or a home monitor, making it the first
integrated system of pacing devices with wireless telemetry from implant
through follow-up. Wireless communication is used when clinicians
implant the device and during follow-up appointments, which can be
performed in the clinic or via remote monitoring from the patient’s home.
“The Accent RF pacemaker and Anthem RF CRT-P are representative of St.
Jude Medical’s dedication to providing early insight into actionable
information for physicians,” said Eric S. Fain, M.D., president of the
St. Jude Medical Cardiac Rhythm Management Division. “The pacemakers
were designed in response to physician and patient needs for devices
that provide timely, actionable information. Using the remote monitoring
capabilities, physicians can more efficiently follow patients, while
patients enjoy the convenience of care from home.”
Patient device follow-up can be scheduled to take place automatically,
in a hands free manner, with no patient interaction required.
Information from the device is then captured by the Merlin@home®
transmitter, and becomes available for viewing by the clinician via
Merlin.net PCN. In addition to fast access to device data, Merlin.net
PCN also allows physicians to compile a more complete patient record, by
easily transferring cardiac device data into electronic health records
The Accent RF pacemaker and Anthem RF CRT-P have several features that
simplify patient management. These features include AT/AF Alerts,
AutoCapture® Pacing System technology that measures the heart’s reaction
to pacing beat-by-beat, and the VIP® algorithm that enables the heart’s
intrinsic rhythm to prevail when appropriate, thereby reducing
unnecessary ventricular pacing.
The AT/AF Alert feature helps to better assist physicians in accurately
diagnosing and managing patients with fast rates in the heart’s upper
chambers, called atria. This feature is designed to notify physicians
when a rapid atrial rate, atrial tachycardia or atrial fibrillation
(AT/AF), exceeds a programmed value or occurs over an extended period of
time. The devices also can be programmed to notify the patient of AT/AF
episodes, as well as device- and lead-related issues, through a two-tone
audible alert. In addition, the patient’s clinic can be informed through
the home monitoring system. These features will allow the physician to
more proactively manage patients’ atrial arrhythmias, such as AF.
“The automatic alerts provided by the RF telemetry built in to the
Accent RF and Anthem RF devices enhance my ability to manage patients’
heart conditions and disease progression, something that is particularly
important for patients with heart failure or other co-morbidities,” said
Steven Greenberg, M.D., coordinator of the Arrhythmia and Pacemaker
Center at St. Francis Hospital in Roslyn, New York. “Rather than
checking the device a few times a year, the daily alerts allow me to
know about important changes in my patient’s condition or device
functions so I can act more quickly in addressing any issues.”
AutoCapture Pacing System technology allows the devices to be programmed
to automatically monitor and adjust the level of electrical energy
needed for stimulating the patient’s heart, confirming that the heart is
responding to the stimulation. This feature provides the dual benefit of
added safety for the patient and increased efficiency for physicians, as
vital threshold tests are performed automatically.
The St. Jude Medical Ventricular Intrinsic Preference (VIP) algorithm
allows the device to monitor the heart beat-by-beat and provide pacing
only when necessary. Allowing the patient’s natural heart rhythm to work
on its own when possible has been shown to benefit overall heart health.
With the combination of advanced features and efficiencies provided by
the company’s consolidated Unity device platform, the Accent RF
pacemaker and Anthem RF CRT-P offer significantly improved battery
longevity and an industry-leading seven-year warranty.
Cardiac pacemakers are used to treat bradycardia, which is a heart rate
that is too slow. These devices monitor the heart and provide electrical
stimulation when the heart beats too slowly for each patient's specific
A CRT-P resynchronizes the beating of the heart's lower chambers
(ventricles), which often beat out of sync in heart failure patients.
Studies have shown that CRT can improve the quality of life for many
patients with heart failure, a progressive condition in which the heart
weakens and loses its ability to pump an adequate supply of blood. An
estimated 5 million Americans suffer from heart failure, with 550,000
new cases diagnosed each year.
About Merlin.net Patient Care Network
Implantable cardiac devices are designed to capture and record
information about device performance and patient heart rhythms that is
vital to patient care. Merlin.net PCN organizes this information for
fast analysis and easy review and allows data to be sent directly to a
clinic or 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 to fit in with physician
determined clinic hours, including any after-hours processes the clinic
Version 4.0 of Merlin.net PCN provides an additional feature called
DirectTrend™ Viewer, which graphically displays patient trends and
disease progression. This allows physicians to more effectively and
efficiently manage patients through interactive views of patient data
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
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 four major focus areas
that include: cardiac rhythm management, atrial fibrillation,
cardiovascular and neuromodulation. For more information, please visit www.sjm.com.
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 Quarterly Report on Form
10-Q for the fiscal quarter ended April 4, 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.
Source: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Amy Jo Meyer, 651-756-3029