System offers physicians additional pacing options and more flexibility
in selecting pacing configurations during and after implant procedures
ST. PAUL, Minn.--(BUSINESS WIRE)--Oct. 20, 2009--
St. Jude Medical, Inc. (NYSE: STJ) today announced it has received
European CE Mark approval for the industry’s first quadripolar pacing
system for cardiac resynchronization therapy defibrillators (CRT-Ds).
The quadripolar system offers physicians the ability to more effectively
and efficiently manage the ever-changing pacing needs of patients with
heart failure. It integrates multiple pacing options and features that
enable physicians to better manage common pacing complications without
having to surgically reposition the lead.
“Managing heart failure patients is often challenging and typically
involves ongoing medical management,” said Dr. Klaus Gutleben,
consultant cardiologist at the Heart and Diabetes Center North
Rhine-Westphalia in Bad Oeynhausen, Germany. “This new quadripolar
pacing system provides more options for managing the needs of my
patients with heart failure and reduces the patient’s risk of needing
multiple surgical procedures, which should lead to more efficient
The quadripolar system, with the Quartet™ left ventricular pacing lead,
features four pacing electrodes on the left ventricular lead – enabling
up to 10 pacing configurations. Multiple pacing configurations provide
physicians with more options to pace around scar tissue in the heart and
avoid common pacing complications without the need to surgically
reposition the lead.
Common pacing complications that can occur in patients implanted with a
CRT system include high pacing thresholds and unintentional phrenic
nerve or diaphragmatic stimulation. Patients with high pacing thresholds
require significantly higher energy to pace the heart; this may reduce
the device’s battery life or cause pacing to fail. Phrenic nerve and
diaphragmatic stimulation occur when the electrical output from a device
inadvertently activates the diaphragm muscle (either directly or via the
phrenic nerve), causing hiccups upon each pacing stimulus. Both high
pacing thresholds and phrenic nerve or diaphragmatic stimulation are
often due to the location of the pacing lead electrode.
“The new features offered in this quadripolar system allow me to
mitigate potential complications that would otherwise require an
invasive procedure to re-place or reposition the left ventricular lead,”
said Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim,
Germany. “Moreover, the lead maintains excellent handling
characteristics, as the additional electrodes do not impact my ability
to place the lead in the targeted vein.”
In addition to multiple pacing options, the Quartet pacing lead features
other St. Jude Medical technologies such as Optim™ insulation – a
material that combines the biostability and flexibility of
high-performance silicone rubber with the strength, tear resistance and
abrasion resistance of polyurethane, to provide increased durability,
flexibility and improved handling characteristics – and the “S-curve”
design of the QuickFlex™ lead family, which increases stability.
“CRT has been demonstrated as an important treatment in reducing
symptoms and slowing the progression of heart failure. This new system
gives physicians more control over patient therapy by providing the
flexibility to non-invasively adjust the pacing location or
configuration,” said Eric S. Fain, M.D., president of the St. Jude
Medical Cardiac Rhythm Management Division. “This approval of the
industry’s first quadripolar pacing system is demonstrative of St. Jude
Medical’s commitment to providing physicians with novel technology that
addresses clinical needs.”
Cardiac resynchronization therapy, which can be delivered in an
implantable cardioverter defibrillator (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. Approximately 23
million people worldwide are afflicted with congestive heart failure
(CHF), and 2 million new cases of CHF are diagnosed each year worldwide.
The quadripolar CRT-D and Quartet pacing lead will be distributed via a
limited launched in Europe, and will be used in the investigational
devices exemption (IDE) trial for U.S. Food and Drug Administration
(FDA) approval of the commercialized device, which will be called the
Promote Quadra™ CRT-D.
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 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 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 Reports on
Form 10-Q for the fiscal quarters ended April 4, 2009 and July 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.
Sara Spafford Freeman, 651-756-6702
Jo Meyer, 651-756-3029