The HeartMate 3™ Left Ventricular Assist System offers
physicians in Europe the most advanced ventricular assist
technology available to support management of patients with
advanced heart failure
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the company has received an Innovation
Award for its HeartMate 3™ Left Ventricular Assist System (LVAS) at
the 2016 CARDIOSTIM EHRA EUROPACE International Congress of
electrophysiology and cardiac technology.
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Dr. Mark Carlson, Chief Medical Officer
at St. Jude Medical and Dr. Philippe Ritter, Chairman of CardioStim
and Heart Rhythm Specialist at the University Hospital of Bordeaux.
(Photo: Business Wire)
Each year, an international panel of experts, scientists and
physicians gather to review the latest in medical technology. The
HeartMate 3 LVAS was awarded in the category of Patient Care
Improvement. The circulatory assist device is available to heart
failure patients as a cardiac support option for advanced heart
failure patients who are awaiting transplantation, are not
candidates for heart transplantation, or are in myocardial
recovery.
The St. Jude Medical™ Nanostim™ leadless pacemaker previously
received the innovation award at CARDIOSTIM 2014.
“The CARDIOSTIM INNOVATION AWARDS aim at honoring the
performance, achievement and cutting-edge technologies designed by
manufacturers that are created to modernize medical practice and
improve patient care,” says Dr. Philippe Ritter, Chairman of
CardioStim and heart rhythm specialist at the University Hospital
of Bordeaux. “The HeartMate 3 cardiac assist device brings real
benefit to patients suffering from heart failure and is an
encouraging solution, in particular, for those awaiting
transplantation.”
The HeartMate 3 LVAS is the first commercially approved
centrifugal-flow left ventricular assist device (LVAD) utilizing
Full MagLev™ technology, which allows the device’s rotor to be
“suspended” by magnetic forces. This design aims to reduce trauma
to blood passing through the pump and improve outcomes for
patients.
“We are honored to receive this prestigious award from the
clinical community for our HeartMate 3 System,” said Dr. Mark
Carlson, vice president of global clinical affairs and chief
medical officer at St. Jude Medical. “Heart failure remains one of
the most costly epidemic diseases in the world, and the HeartMate 3
system is critical to helping physicians manage their complex
patients battling such a challenging condition.”
CE Mark approval for the HeartMate 3 LVAS was based on data from
the HeartMate 3 CE Mark clinical trial, which met its primary
endpoint and demonstrated a 92 percent six month survival rate; the
best six month survival rate to date to be documented in an LVAD CE
Mark clinical study. Enrollment included both bridge-to-transplant
and destination therapy patients in New York Hospital Association
Class IIIb or IV heart failure. In the U.S., the HeartMate 3 LVAS
is in an ongoing IDE trial. The MOMENTUM 3 IDE trial, the largest
of its kind, remains ongoing and will enroll more than 1,000
patients.
The HeartMate 3 LVAS is not approved in the U.S. and limited by
federal law to investigational use.
About Left Ventricular Assist Devices
Unlike artificial hearts, LVADs don’t replace the heart.
Instead, the small implantable devices supplement the pumping
function of the heart in patients whose hearts are too weak to pump
blood adequately on their own. LVADs can benefit patients either
awaiting transplant, known as bridge to transplant therapy, or can
be used as a “destination therapy” for heart failure patients who
need years of cardiac support but who are not candidates for
transplantation.
About the HeartMate 3 Left Ventricular Assist System
The HeartMate 3 LVAS is implanted above the diaphragm,
immediately next to the native heart, and is attached to the aorta
leaving natural circulation in place while providing all of the
energy necessary to propel blood throughout the body. The patient
wears an external, wearable controller and battery system that
powers the pump. The HeartMate 3 LVAS can pump up to 10 liters of
blood per minute. The design of the HeartMate 3 LVAD includes
large, consistent blood flow gaps over a wide range of device
operation levels, designed to reduce blood trauma. The artificial
pulse technology is designed to further reduce adverse patient
events including combating the formation of thrombus in the
device.
About St. Jude Medical’s Heart Failure Business
St. Jude Medical is pioneering heart
failure disease management with innovative solutions like the
CardioMEMS™ HF System, ground-breaking quadripolar technology and,
in select European markets, the HeartMate 3 LVAS and our
first-to-market MultiPoint™ Pacing technology. St. Jude
Medical collaborates with heart failure specialists,
clinicians and advocacy partners to provide innovative,
cost-effective solutions that help reduce hospitalizations and
improve patient quality of life for heart failure patients around
the world.
For more information about St. Jude Medical’s focus on heart
failure, visit the St. Jude Medical Heart Failure Media
Kit or the St. Jude Medical PULSE Blog.
Information for patients to learn more about heart failure can
be found at www.heartfailureanswers.com.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer
dedicated to transforming the treatment of some of the world’s most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul, Minn., St.
Jude Medical has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com or
follow us on Twitter @SJM_Media.
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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2016. 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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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorKristi Warner, 651-756-2085Media
Relationskwarner@sjm.com
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