St. Jude Medical Announces Japanese Launch of Smaller, Higher Power ICD and CRT-D Devices
June 21 2011 - 8:01AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory
approval from the Japanese Ministry of Health, Labor and Welfare
(MHLW) and the launch of the Fortify™ ST implantable cardioverter
defibrillators (ICD) and Unify™ cardiac resynchronization therapy
defibrillator (CRT-D). The reduced footprint of these new devices
makes them the smallest available in the industry.
The Unify CRT-D and Fortify ST ICD 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 DF4
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 and Fortify ST devices were designed to address many
of the clinical issues facing our customers, and at the same time
reduce the size to make them more comfortable for patients,” said
Eric S. Fain, M.D., president of the St. Jude Medical Cardiac
Rhythm Management Division. “We are happy to offer devices in Japan
with the industry’s smallest footprint that will improve disease
management of cardiac conditions.”
The Unify CRT-D and Fortify ST ICD also incorporate the new
CorVue™ monitoring algorithm. This new feature alerts physicians to
variations in thoracic impedance, a measurement that helps
physicians better understand a patient’s heart failure status. The
algorithm continuously monitors thoracic impedance as a surrogate
for fluid retention in multiple vectors, providing information that
may be used to index the level of heart failure.
The devices also feature the company’s ShockGuard technology,
which is designed to reduce inappropriate and unnecessary shocks
for patients. The programming in ShockGuard discriminates between
rhythms that require defibrillation therapy and those that do not.
Additionally, the advanced sensing technology designed to avoid
sensing unwanted signals (T-waves) and offer more anti-tachycardia
pacing options, which can convert many fast ventricular arrhythmias
painlessly and avoid the need for high voltage shocks. A
retrospective analysis of the Advancements in ICD Therapy (ACT)
registry, which enrolled more than 5,000 patients and allowed
programming at the physician's discretion, demonstrated that at the
end of one year, 98.5 percent of patients with the ShockGuard
programming would be free of inappropriate shocks.
“The size and shape of the Unify and Fortify ST devices are
significantly smaller than that of the current devices, which is
truly helpful as patients in Japan tend to be smaller than those in
Western countries,” said Dr. Hideo Okamura from the National
Cerebral and Cardiovascular Center in Osaka, Japan. “Although
smaller, these devices have an extended longevity and a stronger
output of energy for shock therapy. Taken together, I believe that
these enhanced features will improve patient care.”
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).
Dr. Takashi Noda from the National Cerebral and Cardiovascular
Center added, “It is very important for us as physicians to utilize
as many indications and diagnostic data as we can for each heart
failure patient therapy and follow up. In addition to the
additional data provided with the CorVue, the new devices also have
new features and settings that help to reduce inappropriate and
unnecessary shock therapy.”
With the device's monitoring diagnostic, small changes in ST
segment are continuously and precisely recorded and plotted, and
then retrieved for the physician to review during patient follow-up
visits. Because many cardiac episodes are transient in nature,
continuous ST Monitoring is important as it gives physicians more
comprehensive ST segment information over time rather than sporadic
diagnostic reports when the patient is in the clinic or
hospital.
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 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. St. Jude Medical is headquartered in
St. Paul, Minn. 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 Annual Report on Form 10-K for the fiscal year ended
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2011. 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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