St. Jude Medical Announces European Launch of Smaller Quadripolar Pacing System
September 20 2011 - 8:02AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the European launch of the Unify Quadra™
cardiac resynchronization therapy defibrillator (CRT-D). The Unify
Quadra CRT-D works with the company’s Quartet™ left ventricular
pacing lead. The combined system offers physicians the ability to
effectively and efficiently manage the changing pacing needs of
patients with heart failure with a downsized quadripolar pacing
system. In Europe, heart failure affects more than 14 million
people, and is projected to affect about 30 million by 2020.
St. Jude Medical introduced quadripolar technology last year in
Europe with the Promote Quadra™ CRT-D, and is the only company to
offer quadripolar technology. The system integrates multiple pacing
configurations and features that enable physicians to optimize the
system at implant and throughout the life of the patient, as well
as better manage common pacing complications without exposing the
patient to additional surgeries to reposition the lead.
The Unify Quadra is the next generation of the technology,
providing all the benefits of quadripolar technology in a device
with the industry’s smallest footprint. The device’s narrower shape
allows physicians to implant the system using a shorter incision,
with less time spent closing the incision, and a smaller scar for
the patient.
The Unify Quadra uses the new International Standards
Organization (ISO) DF4 and IS4 connector specifications to further
streamline the procedure. The DF4 connector reduces 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 IS4 connector enables four electrodes to
be used on the Quartet left ventricular pacing lead while
connecting to a single standard connector on the Unify Quadra
device.
The Quartet left ventricular pacing lead – used as part of the
Unify Quadra system – features four electrodes, instead of the
usual two. Multiple pacing configurations allow the physician more
options, including pacing closer to the base of the left ventricle,
which recent studies associate with better patient outcomes and
which may be less possible with traditional leads that only have
two electrodes. The quadripolar pacing electrodes also provide
physicians additional benefits, such as pacing around scar tissue
in the heart and avoiding the most common pacing complications.
Commenting on the technology, Dr. Amir Zaidi, consultant
cardiologist at the Central Manchester University Hospitals NHS
Foundation Trust, said, “Diaphragmatic stimulation is the most
common implant-related problem that prevents my patients from
receiving effective cardiac resynchronization therapy. Unify Quadra
is my “go to” technology in these cases and I believe its benefits
can make it the standard of care for cardiac resynchronization.
With quadripolar technology, I can deliver effective treatment to
patients who would otherwise be denied gold-standard therapy for
heart failure using conventional CRT devices.”
Because the physician can non-invasively adjust pacing locations
or configurations, the technology has the potential to reduce
patients’ risk of needing multiple surgeries. This is important
because some complications, such as phrenic nerve or diaphragmatic
stimulation are body-position sensitive and may not be evident
while patients are lying on their back during the implantation
procedure. More than thirty publications provide clinical evidence
supporting the benefits of the quadripolar technology in managing
common pacing complications, enabling better clinical efficiency,
and providing a greater opportunity for efficacy.
“This new system is designed to manage the dynamic challenges of
heart failure,” said Eric S. Fain, M.D., president of the St. Jude
Medical Cardiac Rhythm Management Division. “Based on the clinical
evidence, positive experiences and publications to date, this
innovative CRT system has the potential to redefine the standard of
care in resynchronization therapy for heart failure patients around
the world.”
In heart failure patients, the heart often beats out of sync.
Cardiac resynchronization therapy resynchronizes the beating of the
heart by pacing both lower chambers (ventricles) rather than just
one (the right ventricle). 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. Currently, heart
failure results in more than 3.6 million hospitalizations per year
in Europe, and related costs represent approximately 2 percent of
overall health care expenditures.
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 July 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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