New Streamlined Design Expected to Offer Implanting Physicians a More Efficient Procedure and Improve Patient ComfortST. PAUL, Minn., Jun 10, 2009 (BUSINESS WIRE) -- St. Jude Medical, Inc. (NYSE:STJ) today announced the first implant of
its Current(R) Plus implantable cardioverter defibrillator (ICD),
featuring the SJ4 connector system. The St. Jude Medical SJ4 connector
reduces the number of connections between the device and the wires
(defibrillation leads) that send electrical impulses to the heart, which
is intended to enable a streamlined implant procedure.
The SJ4 connector system features a single connection between the device
and the defibrillation lead, and a single set screw (used to tighten and
secure the lead to the device). Previous defibrillator lead designs
required three separate connections and four set screws. The reduced
number of lead connections also lessens the risk of lead-to-can
abrasion, a known complication that can occur in patients who have an
implantable device.
"With only a single connection and one set screw, the SJ4 connector has
the potential to improve the implant procedure, may reduce
the lead volume under the ICD in the chest wall and may improve patient
comfort," said Cleveland Clinic's Bruce Wilkoff, M.D., who is on the
company's physician lead review board and has sponsored research with
St. Jude Medical, Inc. Dr. Wilkoff implanted the first Current Plus ICD
with SJ4 connector on June 4, 2009. "This design is intended to reduce
the risk of incorrect connections of the lead to the ICD and reduce
procedure time."
The St. Jude Medical SJ4 connector system is designed to meet the draft
IS-4 standard as set forth by the International Organization of
Standardization (ISO) but will not be labeled as such until the standard
is finalized, which is expected later this year. St. Jude Medical began
launch of the SJ4 connector system after ISO-directed interchangeability
testing among multiple manufacturers was completed. This testing was
deemed an important step in ensuring that these new leads, which
currently meet the drafted IS-4 standard, would be compatible with
future implanted devices.
"Simplifying the lead connection process is one of many design features
we have incorporated as part of our commitment to making procedures
safer for patients and more efficient for physicians, from implant
through follow-up," said Eric S. Fain, M.D., president of the St. Jude
Medical Cardiac Rhythm Management Division. "This aligns with our
strategy of reducing lead risks and increasing reliability, which
includes technology designed to reduce lead-to-can abrasion and sensing
of far-field ventricular signals in the atrium."
The Current Plus ICD was approved by the FDA in April 2009, along with
the company's Promote(R) Plus cardiac resynchronization therapy
defibrillator (CRT-D), which are compatible with the Durata(R) SJ4
defibrillation lead. As with previously announced leads in the Durata
lead family, the Durata lead with SJ4 connector features a soft silicone
tip and Optim(R) insulation, a hybrid insulation material that provides
increased abrasion-resistance and durability, along with the flexibility
and handling characteristics that facilitate device implantation.
Both devices are built on the St. Jude Medical Unity platform, a
consolidated hardware and software unified device interface, and include
advanced safety features and algorithms for improved patient management,
including TailoredTherapy(TM) features that allow physicians to
customize therapy to individual patient needs. The devices also feature
improved lead monitoring capabilities, including daily checks of all
pacing and shock configurations, and have the ability to inform the
patient's clinic, via the St. Jude Medical Merlin@home(R) transmitter and
Merlin.net(TM) Patient Care Network (PCN), of any critical system changes.
As a requirement for FDA approval, St. Jude Medical is conducting a
post-approval study featuring the SJ4 connector that will enroll up to
1,700 patients and follow them 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.
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.
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.
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 Quarterly Report on Form
10-Q for the fiscal quarter ended April 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.
Angela Craig, 651-756-2191 (Investor Relations)
acraig@sjm.com
Amy Jo Meyer, 651-756-3029 (Media Relations)
ameyer@sjm.com
