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St. Jude Medical, Inc.
Global Headquarters
One St. Jude Medical Drive
St. Paul, MN 55117-9913 USA
Tel 651 756 2000
sjm.com
News Release
CONTACTS:
J.C. Weigelt
Investor Relations
Tel 651 756 4347
[email protected]
Marisa Bluestone
Media Relations
Tel 651 756 6739
[email protected]
St. Jude Medical Announces Indian Launch of Smaller Quadripolar Technology to Treat
Heart Failure
ST. PAUL, Minn. – July XX, 2012 – St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the Indian 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 to offer a smaller quadripolar pacing system that helps physicians effectively and efficiently
manage the changing pacing needs of patients with heart failure.
Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. It
results in the build-up of fluids throughout the body, which can lead to shortness of breath, swelling, and
heart rhythm abnormalities. The Unify Quadra CRT-D system was designed to help the heart perform in
its most natural state by synchronizing the left and right ventricles of the heart through timed electrical
pulses.
St. Jude Medical first introduced quadripolar technology to India in 2011 with the launch of the Promote
Quadra™ CRT-D, and remains the only company offering quadripolar technology anywhere in the world.
The Unify Quadra is the next generation of the technology, providing all the benefits of quadripolar
pacing technology in a smaller device.
The quadripolar system integrates multiple pacing configurations and features that provide physicians
with more options to better manage common pacing complications without exposing the patient to
additional surgeries in order to reposition the lead. This is important because approximately one in 10
patients who receive a CRT system have complications that could require an additional surgery. To date,
more than fifty publications have provided clinical evidence supporting the benefits of quadripolar
technology to manage common pacing complications, enable better clinical efficiency and provide a
greater opportunity for efficacy.
The Unify Quadra CRT-D works with the company’s Quartet™ left ventricular pacing lead. It features
four electrodes, rather than the conventional two or less. The additional electrodes allow for multiple
pacing configurations, which provide the physician with more pacing options. This includes the ability to
pace closer to the base of the left ventricle, which research has consistently shown to provide better
patient outcomes and can be difficult to achieve with the conventional two-electrode lead. The
quadripolar pacing electrodes also allow physicians to avoid the most common kinds of pacing
complications and to pace around scar tissue found in the heart.
Commenting on the technology, Dr. Aftab Ashrafuddin Khan, Senior Interventional Cardiologist and
Director of Electrophysiology Services ay Apollo Gleneagles Hospitals in Kolkata said, “With the Unify
St. Jude Medical, Inc.
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Quadra technology, I have more pacing options available than conventional CRT therapy, and also with
a smaller device. This provides multiple benefits; first it improves the probability that a patient will
respond well to the therapy, and second it helps patients avoid common complications by allowing for
any adjustments of the leads without surgical revision.”
Due to differences in individual patient anatomy, or results that can’t be seen until the procedure is
complete, complications can arise after placing the lead of a CRT device. One example of a pacing
complication is a high pacing threshold. Patients who already have scar tissue formed in the heart,
possibly as a result of a previous heart attack, may require additional energy from their CRT device,
which can wear out the battery more quickly. Another complication that can result is the unintentional
stimulation of the diaphragm from pacing the phrenic nerve, which results in hiccup-like symptoms. The
Quartet lead’s four electrodes can help avoid these complications by providing physicians more options
to choose alternative pacing sites without having to relocate the lead either during or with a second
surgery.
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 until after the patient leaves the hospital.
“The launch of the Unify Quadra reflects St. Jude Medical’s ongoing commitment to launching our most
innovative technologies in India,” said Kaustav Banerjee, Managing Director of St. Jude Medical India.
“Based on positive implant experiences with both Promote and Unify Quadra technologies and published
research we believe that this innovative CRT system is making a difference in the lives of patients with
heart failure.”
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 help improve patient comfort by
reducing the bulk of wires in a 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.
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
St. Jude Medical, Inc.
Global Headquarters
One St. Jude Medical Drive
St. Paul, MN 55117-9913 USA
Tel 651 756 2000
sjm.com
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 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2012. The Company does not intend to update these statements and undertakes no duty to
any person to provide any such update under any circumstance.