St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors
February 04 2010 - 9:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced European CE
Mark approval and first implants of its Fortify™ and Fortify ST
implantable cardioverter defibrillators (ICD) and Unify™ cardiac
resynchronization therapy defibrillator (CRT-D). The devices will
be fully launched in Europe later this spring, and U.S. versions of
the Fortify ICD and Unify CRT-D are expected to be launched later
this year. The reduced size of these new devices compared to those
of previous generations creates the smallest available device
footprint in the industry.
The Fortify ICD and Unify CRT-D feature advanced battery
technology and circuitry that allow for a smaller device, with more
energy capacity and rapid charge times, all while increasing device
longevity. The energy capability of a device is particularly
important for patients who have an enlarged heart, low
ejection-fraction, advanced heart failure or previously
demonstrated a high defibrillation threshold (the amount of energy
required to shock the heart back to a normal rhythm). These devices
feature 40J of delivered energy (45J stored) – the highest energy
level available in the industry – helping to ensure that therapy
will be successful for those patients who require a higher energy
shock for defibrillation.
Because of the devices’ narrower shape, physicians can implant
them using a shorter incision, leading to less time spent closing
the incision and a smaller scar for the patient. The company’s SJ4
lead connector system further streamlines the procedure by reducing
the number of connections between the defibrillation lead and the
device, which can improve patient comfort by reducing the bulk of
wires in the patient’s chest.
The Unify CRT-D and Fortify ICD also incorporate the new CorVue™
pulmonary congestion monitoring algorithm. This new feature alerts
physicians when a patient’s heart failure may be worsening, as
evidenced by changes in electrical signals that can be correlated
to increased congestion, or fluid retention, in the chest area. The
algorithm continuously monitors fluid retention in multiple
vectors, providing an accurate diagnostic and an alert designed to
minimize false positives.
“These new devices have been designed to address many of the
clinical issues facing our customers, from enhanced patient safety,
reduction of inappropriate therapy and streamlined implant
procedures, to improved disease management of cardiac conditions,”
said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac
Rhythm Management Division. “Our goal with this product line is to
address all these needs and do so while reducing the size of the
device without compromising on either delivered energy or device
longevity.”
Both devices also have features that are designed to assist in
the reduction of unnecessary shocks, including painless
anti-tachycardia pacing, which can be used for fast ventricular
arrhythmias prior to or while the device is preparing to deliver
shock therapy, and other enhanced technology for reducing
inappropriate therapy.
“This new device platform provides a number of new features that
will help me to improve management of my patients with ICD and
CRT-D devices, while delivering new safety features on top of St.
Jude Medical’s already reliable technology,” said Prof. Werner Jung
of Schwarzwald-Baar Klinkum in Villingen-Schweningen, Germany. “The
combination of the devices’ smaller size and SJ4 connector system
also streamlines the implant procedure and makes the device more
comfortable for my patients.”
In addition to the family-wide features of the Unify and Fortify
devices, the Fortify ST ICD features St. Jude Medical’s
first-to-market ST segment monitoring diagnostic algorithm, which
can add important information to assist in medical decision making
and accelerate patient care. The Fortify ST ICD continuously
monitors for specific changes in the ST segment of the
electrocardiogram that can indicate the onset of serious conditions
such as ischemia (which occurs when blood flow/oxygen to the heart
muscle is obstructed). Because many cardiac episodes are transient
in nature, the continuous ST monitoring capability available in the
Fortify ST ICD gives physicians more comprehensive information over
time compared to the standard electrocardiogram (ECG or EKG) that
would otherwise only be recorded in the physician’s office.
An ICD is an advanced implantable device that treats potentially
lethal, abnormally fast heart rhythms (ventricular tachycardias or
ventricular fibrillation), which often lead to sudden cardiac death
(SCD). Approximately 325,000 people per year in the U.S. die
suddenly of SCD.
A CRT-D device resynchronizes the beating of the heart's lower
chambers (ventricles), which often beat out of sync in heart
failure patients, and provides back up treatment for SCD, which is
a risk factor associated with certain types of heart failure.
Studies have shown that CRT (cardiac resynchronization therapy) 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.
The Unify CRT-D and Fortify ICD are pending approval by the U.S.
Food and Drug Administration (FDA).
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.
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 Reports on Form 10-Q for the fiscal quarters
ended April 4, 2009, July 4, 2009 and October 3, 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.
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