St. Jude Medical Announces CE Mark Approval for the HeartMate 3 Left Ventricular Assist System
12 October 2015 - 11:00PM
Business Wire
With approval, the HeartMate 3 System offers physicians in
Europe the most advanced ventricular assist technology available to
support the management of patients with advanced stage heart
failure
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the company has received CE Mark approval
for the HeartMate 3™ Left Ventricular Assist System (LVAS), a
cardiac support option for advanced heart failure patients who are
awaiting transplantation, are not candidates for heart
transplantation, or are in myocardial recovery.
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“The advanced heart failure medical community has eagerly
anticipated the expected clinical improvements with the HeartMate 3
system and looks forward to its broad adoption throughout Europe,”
said Professor Friedhelm Beyersdorf, Medical Director, Department
of Cardiovascular Surgery, Heart Center Freiburg University.
The HeartMate 3 system is the first commercially approved
centrifugal-flow left ventricular assist device (LVAD) utilizing
Full MagLev™ (fully magnetically-levitated) 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.
The device 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.
CE Mark approval for the HeartMate 3 system 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. St. Jude Medical expects a limited market
release across Europe to begin immediately, with additional market
releases taking place throughout 2016.
“We are pleased to announce CE Mark approval of the
next-generation HeartMate 3 system, which has been proven through
the HeartMate 3 CE Mark study to show high survival rates, material
improvements in functional status, and very low adverse event rates
highlighted by zero pump thrombosis events,” said Eric Fain, M.D.,
group president 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 supporting physicians managing the care of
patients battling such a complex and challenging condition.”
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.
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
combatting the formation of thrombus in the device.
The HeartMate 3 CE Mark clinical trial, which concluded in
November 2014, enrolled 50 patients at 10 hospitals in six
countries outside the U.S. Enrollment included both
bridge-to-transplant and destination therapy patients in New York
Hospital Association Class IIIb or IV heart failure. The study met
its primary endpoint by demonstrating a six month survival rate of
92 percent with the HeartMate 3 LVAS, as well as overall adverse
event rates that were either lower or consistent with expectations
for severely ill and complex patients requiring LVAD support. In
the U.S., the HeartMate 3 system 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.
About the HeartMate 3 Left Ventricular Assist System
The HeartMate 3 LVAS includes a centrifugal blood pump that is
implanted directly onto a patient's native heart and designed to
supplement the pumping ability of the weakened heart's left
ventricle, which is responsible for pumping oxygen-rich blood from
the lungs throughout the body. The device is implanted above the
diaphragm, immediately next to the native heart, and is attached to
the aorta (the main artery that feeds blood into the entire body),
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.
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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 4, 2015. 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.Kristi Warner, 651-756-2085Media
Relationskwarner@sjm.comorJ.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.com
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