St. Jude Medical, Inc. (NYSE:STJ) today announced the first
European implant of its new wireless device to treat patients with
heart failure. The Promote(TM) RF CRT-D (cardiac resynchronization
therapy defibrillator) features 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 device uses 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.
"RF wireless technology eliminates the need for programming wands
and cables, allowing device testing, interrogation and programming to
be easier and less cumbersome," said Johannes Sperzel, M.D., who
performed the first European implant of the Promote RF CRT-D at
Kerckhoff-Klinik in Bad Nauheim, Germany. "These new wireless devices
provide greater speed during implant and at follow-up, along with
added security and safety."
St. Jude Medical received European CE Mark approval of the Promote
RF CRT-D earlier this month, along with the company's new wireless
Current(TM) RF ICD (implantable cardioverter defibrillator).
"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 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.)
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.
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.
Both the Promote RF CRT-D and Current RF ICD also include these
proprietary technologies from St. Jude Medical:
-- QuickOpt(TM) 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.
-- VIP(R) (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.
-- DeFT Response(TM) technology - which is designed to help
devices meet the needs of patients with high or varying defibrillation
thresholds.
-- SenseAbility(TM) 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.
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
pages 13-20) and Quarterly Report on Form 10-Q filed on May 9, 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.