St. Jude Medical Announces European Approval of Company's First Wireless ICD and CRT-D Heart Failure Devices
May 08 2007 - 3:00PM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark
approval of its first wireless devices to treat patients with heart
failure and with potentially lethal heart arrhythmias. The Promote�
RF CRT-D (cardiac resynchronization therapy defibrillator) and
Current� RF ICD (implantable cardioverter defibrillator) feature
radiofrequency (RF) telemetry for wireless communication with
programmers used by physicians to interrogate and program devices.
RF telemetry enables secure, remote communication between the
implanted device and the programmers in a clinician�s office.
Wireless communication occurs while the device is being implanted
and when patients see physicians for follow-up visits, allowing for
efficient, more convenient care and device management. The devices
use a dedicated range of frequencies designated for medical devices
called the MICS (Medical Implant Communications Service) frequency
band, which helps to prevent interference from other electronic
signals. The Promote RF CRT-D and Current RF ICD are built on St.
Jude Medical�s next generation �Unity� device platform. This
consolidated electronics platform will enable St. Jude Medical to
more quickly introduce devices with new features and diagnostics,
as they become available, because the basic platform for all of the
devices is the same. In addition, the consolidated platform�s
expanded capabilities can support more advanced algorithms and
features for better patient management. Furthermore, programming
during device follow-up will be streamlined, as all software
interfaces for new St. Jude Medical pacemakers, ICDs and CRT
devices will be the same. The Promote RF CRT-D allows physicians to
electronically reconfigure left ventricular (LV) leads to help
optimize the pacing performance without the need to physically
reposition the lead. (A lead is a thin, insulated wire, connected
to the heart tissue on one end and to the device on the other end.
It transmits electrical impulses to the heart, and information from
the heart back to the implanted device, so physicians can use it
for diagnoses. LV leads are placed in the lower left chamber of the
heart.) In addition, the VIP� (Ventricular Intrinsic Preference)
algorithm is designed to allow the patient�s own heart rhythm to
prevail when possible. VIP technology actively monitors the heart
on a beat-by-beat basis to provide pacing only when needed, which
has been shown to be better for patients� overall heart health.
Both devices also feature new patient management tools, such as
enhanced patient exercise monitoring that gives the physician
information about patient activity levels. Improved lead monitoring
capabilities�including daily checks of all pacing and shock
configurations�provide added patient safety. The Promote RF CRT-D
and Current RF ICD also include these proprietary technologies from
St. Jude Medical: QuickOpt� Timing Cycle Optimization - A
programmer-based optimization method for people with CRT-Ds and
ICDs that helps physicians quickly program the device's timing
cycles � in about 90 seconds � to help deliver optimal therapy to
patients. As demonstrated in clinical studies, the QuickOpt feature
produces results that are comparable to optimization guided by
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 with high or
varying defibrillation thresholds. SenseAbility� technology � which
is designed to optimize sensing to help protect against
inappropriate shocks. Vibrating patient notifier - The industry's
only notifier that gently vibrates to notify patients of critical
changes in device performance instead of issuing the standard audio
alert; this can be especially beneficial for people with hearing
loss. �With wireless capability, physicians can quickly and
securely implant devices without the need for a wand in the sterile
field,� said Michael J. Coyle, president of St. Jude Medical�s
Cardiac Rhythm Management Division. �This adds speed, efficiency
and convenience to the implant procedure and follow-up visits.� The
Promote RF CRT-D and Current RF ICD devices are two of more than 20
new cardiac rhythm management products being introduced this year
by St. Jude Medical. 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 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 more than 11,000 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 Item 1A on pages 13-20,
and page 20 of Exhibit 13 to the Company�s Form 10-K). The Company
does not intend to update these statements and undertakes no duty
to any person to provide any such update under any circumstance.
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