ST. PAUL, Minn.--(BUSINESS WIRE)--May. 11, 2009--
Please replace the release with the following corrected version due to
publication of incorrect Forward-Looking Statements.
The corrected release reads:
ST. JUDE MEDICAL ANNOUNCES FDA APPROVAL OF CURRENT PLUS ICD AND
PROMOTE PLUS CRT-D DEVICES TO PROVIDE THERAPY FOR LIFE-THREATENING
ARRHYTHMIAS AND HEART FAILURE
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug
Administration (FDA) approval of the Promote® Plus cardiac
resynchronization therapy defibrillator (CRT-D) and Current® Plus
implantable cardioverter defibrillators (ICDs), designed with TailoredTherapy™
features that give physicians more options for customizing therapy for
patients with potentially lethal heart arrhythmias and heart failure.
“There is no ‘text book’ patient. Each person presents a unique anatomy,
disease state and response to therapy,” said Eric S. Fain, M.D.,
president of the St. Jude Medical Cardiac Rhythm Management Division.
“With the feature set available in the Promote Plus and Current Plus
devices, physicians can customize programming to ensure each patient is
receiving therapy that is appropriate for his or her individual
The Promote Plus CRT-D and Current Plus ICDs also offer a smoother
header configuration designed to offer better patient comfort and
improve visibility at the connector site, where the thin wire (called a
lead) that delivers the electricity from the device to the heart is
To better assist physicians in accurately diagnosing and managing
patients with fast rates in the heart’s upper chambers (atria), the
Promote Plus CRT-D and Current Plus ICDs also include a new atrial
tachycardia/atrial fibrillation (AT/AF) Alert feature. This feature is
designed to notify physicians when a rapid atrial rate exceeds a
programmed value and occurs over an extended time period. These devices
can also be programmed to notify the patient through a unique vibratory
alert that has been clinically 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.
The Promote Plus CRT-D and Current Plus ICDs are built on the St. Jude
Medical consolidated hardware and software “Unity” device platform and
include the company’s advanced safety features and algorithms for better
patient management. These include improved lead monitoring capabilities
– including daily checks of all pacing and shock configurations – that
provide added patient safety.
TailoredTherapy features in these devices include:
QuickOpt® timing cycle optimization - a programmer-based optimization
method that is proprietary to St. Jude Medical that is used with
CRT-Ds, CRT-Ps (cardiac resynchronization therapy pacemakers) and ICDs
to help physicians quickly program the device's timing cycles – in
about 90 seconds - to help deliver optimal therapy to patients
DeFT Response® technology - designed to help devices meet the needs of
patients with high or varying defibrillation thresholds, helping
physicians to ensure appropriate delivery of life-saving therapy
VIP® (Ventricular Intrinsic Preference) algorithm - provides a delay
in device stimulation of the lower chambers of the heart (ventricles)
to allow the patient's own heart rhythm to prevail when possible. The
VIP technology is designed to provide device stimulation only when
needed, which has been shown to be better for patients' overall heart
SenseAbility® technology - designed to enable physicians to
program the device to more accurately sense abnormal heart rhythms,
thereby protecting the patient from receiving 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). Nearly 1,000 people every day and more than 350,000 every year in
the U.S. die from SCD. An ICD delivers potentially life-saving therapy
from the device to the patient's heart through an insulated wire or lead.
Cardiac resynchronization therapy - delivered in an ICD or a pacemaker -
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. About 5 million
Americans suffer from heart failure, with 550,000 new cases diagnosed
every year, according to the American Heart Association.
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 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.
Source: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Jo Meyer, 651-766-3029