St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and
Drug Administration (FDA) approval of the industry�s first medical
device system that allows a single defibrillation lead connection
between a cardiac resynchronization therapy defibrillator (CRT-D)
and the wires (leads) that send electrical impulses to the heart to
treat the symptoms of heart failure.
The new connector system, which includes the Durata�
defibrillation lead with the SJ4 connector and the Promote� CRT-D
with the SJ4 connector, is expected to make the overall procedure a
simpler process. In addition, the new system reduces the volume of
the leads and device in the chest pocket, which could lessen the
risk of lead-to-can abrasion, a known complication.
The SJ4 connector system features a single connection between
the CRT-D and the defibrillation lead and a single set screw.
Current lead designs require three separate connections and four
set screws. The St. Jude Medical SJ4 connector system was designed
to meet the draft International Organization of Standardization
(ISO) IS-4 standard but will not be labeled as such until the
standard is published, which is expected later this year.
�By simplifying the lead connection process, the physician will
be able to reduce procedure time for both initial implants and
future device replacements,� said Eric S. Fain, M.D., president of
the St. Jude Medical Cardiac Rhythm Management Division. �The SJ4
connector system also requires less lead and device volume in the
body than previous designs, which could reduce the risk of lead
abrasion as well as provide additional comfort to the patient.�
As a requirement of the FDA approval, St. Jude Medical will
conduct a post-approval study that will enroll up to 1,700 patients
and follow the group for five years. The company will also be
gathering data on this new connector system as part of its ongoing
SCORE patient registry, designed to track long-term data on system
performance for all products, including new technology.
�We are pleased to be the industry leader in bringing this
important new connector system to the U.S. market,� said Dr. Fain.
�We look forward to working with the FDA to track the long-term
benefits that we believe this technology will provide.�
St. Jude Medical will begin a limited release over the coming
months and expects a full release of the product later this year.
St. Jude Medical will continue to offer its other standard
connector systems so that physicians can select a device
configuration based on their preference and the individual needs of
their patient.
A defibrillation lead is a long insulated wire that serves as a
conduit between an implanted device and the heart. The lead sends
electrical signals from the device to the heart to provide therapy
needed to address abnormal heart rhythms. The lead also carries
information from the heart back to the implanted device, where the
data can be used by the device to deliver therapy or make automatic
adjustments, and used by physicians to determine optimal device
settings and therapies for each patient.
As with previously announced leads in the Durata lead family,
the Durata lead with SJ4 connector features a soft silicone tip and
Optim� insulation, a hybrid insulation material that provides
increased durability, along with the flexibility and handling
characteristics that facilitate device implantation.
The new Durata lead is the same diameter as the company�s
current Durata high-voltage lead which, at 7 French, is the
smallest diameter high-voltage lead on the market. Small diameter
leads may be especially helpful for patients with compromised blood
flow or a narrow vasculature, or patients who need CRT-D systems
that require three leads to be placed in a single vessel.
The design of the Durata lead is based on the Riata� lead
platform, which has been proven to have excellent performance and
reliability. Recent studies�which analyzed the experience of 7,498
patients and more than 680 implanting physicians at more than 370
sites�found that performance and reliability of Riata leads are
excellent, with very low adverse event rates for all categories of
lead-related complications, including fracture, insulation
abrasion, perforation and dislodgment.
The Promote CRT-D is an implantable cardiac resynchronization
therapy defibrillator for the treatment of heart failure. Like its
predecessor product, the Promote CRT-D with the SJ4 connector
includes features designed to customize treatment to each patient�s
unique needs. Built on the St. Jude Medical consolidated hardware
and software �Unity� device platform, the Promote CRT-D includes
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.
With this system, physicians are able to monitor changes in the
patient�s heart and device therapy via remote transmissions from
the St. Jude Medical Merlin@home� transmitter (a remote monitoring
system in patients' homes), and receive alerts through the
Merlin.net� Patient Care Network (PCN). The St. Jude Medical
vibratory patient alert is 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.
Additional industry-leading features inside 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 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 -
which is 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
- SenseAbility� technology - which
is designed to enable physicians to program the device to more
accurately sense abnormal heart rhythms, thereby protecting the
patient from receiving inappropriate shocks
Heart failure is a progressive dysfunction of the heart�s
pumping action due to the heart�s inability to contract or relax
properly. For the heart to work correctly, the main pumping
chambers (the ventricles) must beat in a coordinated manner. In
some heart failure patients, this coordination may be interrupted.
The right and the left sides fail to beat in synchrony (together)
and can actually work against each other.
Cardiac resynchronization therapy delivers electrical impulses
to heart muscle in the two lower chambers, or ventricles. Called
biventricular pacing, this causes both ventricles to contract at
almost the same time, like in a normal heart. The goal of CRT is to
synchronize the two ventricles (RV and LV) for optimal contraction,
improving the efficiency of each contraction of the heart and the
amount of blood pumped to the body. This therapy helps physicians
lessen the symptoms of heart failure for their patients and, in
many cases, helps to slow the progression of the disease.
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
five major focus areas that include: cardiac rhythm management,
atrial fibrillation, cardiac surgery, cardiology and
neuromodulation. 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 Risk Factors and Cautionary Statements sections of the
Company�s Annual Report on Form 10-K for the fiscal year ended
December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal
quarter ended September 27, 2008. 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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