St. Jude Medical Expands Portfolio of MRI-Compatible Devices to High Voltage in Europe
May 13 2015 - 8:00AM
Business Wire
CE Mark approvals further strengthen the company’s portfolio of
MRI-compatible devices
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced CE Mark approval of expanded labelling for
its Ellipse™ implantable cardioverter defibrillator (ICD), in
addition to its Durata™ and Optisure™ defibrillation leads,
allowing existing or future patients with these technologies to
undergo magnetic resonance imaging (MRI) scans without compromising
device performance. The company also announced today that it has
received CE Mark approval for its Assurity MRI™ and Endurity MRI™
pacemaker device families. The approvals further expand St. Jude
Medical’s MRI-conditional device portfolio in Europe.
CE Mark approval of expanded labelling
for the Ellipse ICD allows existing and future patients with this
technology to undergo MRI scans. (Photo: Business Wire)
“St. Jude Medical is committed to providing MRI-compatible
solutions for its ICD and pacemaker devices for patients and
physicians worldwide,” said Eric S. Fain, M.D., group president of
St. Jude Medical. “These products are already proven cardiac rhythm
management technologies and now, due to extensive research and
testing, they are available in the MRI environment. We will
continue to develop advanced MRI-compatible technologies in order
to ensure patient access to this important diagnostic tool.”
Designed to offer patients added protection in the event of a
life-threatening arrhythmia, the Ellipse device is among the
smallest and most advanced ICDs today. The device uses the
company’s DynamicTx™ algorithm, which automatically adjusts
shocking configurations for patients in order to ensure the
delivery of high-voltage therapy if an electrical short occurs in
one part of the system. The Ellipse ICD also utilizes DeFT
Response™ technology, allowing for physicians to customize the
amount of energy delivered for each individual patient, in addition
to low friction coating on the device can. The added coating has
been demonstrated in testing to significantly reduce the friction
between the device and leads, potentially reducing lead-to-can
abrasion, which is one of the most common types of insulation
failure in the industry.
“It’s not uncommon for patients with cardiac devices to have an
unrelated medical need for an MRI scan over the lifetime of their
device,” said Amir Zaidi, M.D., consultant cardiologist at the
Manchester Royal Infirmary in Manchester, U.K. “The growing
availability of MRI-compatible technologies offered by St. Jude
Medical is significant for patients, because it now means they will
have access to this important diagnostic tool without compromising
their device performance.”
The Assurity MRI and Endurity MRI devices are the world’s
smallest, longest-lasting wireless pacemakers available to patients
today. These devices allow early notification of atrial
fibrillation-related events and pacing that helps reduce heart
failure-related hospitalizations. Both pacemakers are supported by
the Merlin.net™ Patient Care Network (PCN) website for remote
patient management.
In the coming months, St. Jude Medical anticipates updated
labeling for many of its existing cardiac rhythm management
devices, which will allow more patients the ability to safely
undergo MRI scans. St. Jude Medical is planning to submit test data
in key markets around the world in 2015 for MRI conditional
labeling on additional existing high-voltage products including the
Fortify™ Assura ICD, Quadra Assura CRT-D, and Quartet LV leads.
About Cardiac Rhythm Management Devices
An ICD is an advanced implantable device that treats potentially
lethal, abnormally fast heart rhythms, which often lead to sudden
cardiac death (SCD). A pacemaker is a small implantable device that
sends electrical pulses to the heart if the heart is beating too
slowly. Each year, more than one million pacemakers and 300,000
ICDs are implanted worldwide.
A lead is a thin insulated wire that is placed through the vein
as part of a pacemaker or ICD implantation procedure. The tip of
the lead is attached to the heart tissue, and the other end
connects to the pacemaker or ICD. A lead carries electrical
impulses from the pacemaker or ICD to the heart and transmits
information from the heart back to the implanted device.
About St. Jude Medical’s Arrhythmia Business
St. Jude Medical's arrhythmia business, based in St. Paul,
Minn., is one of the fastest growing divisions within St. Jude
Medical. A leader in collaborating with world-renowned
electrophysiologists, clinicians and hospital administrators, St.
Jude Medical develops safe and cost-effective treatment solutions
for patients in need of advanced cardiac rhythm devices.
For more information about St. Jude Medical’s focus on
arrhythmia management, visit SJM
newsroom/arrhythmias-stroke-prevention.
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 April 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.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20150513005528/en/
St. Jude Medical, Inc.Investor Relations:J.C. Weigelt,
651-756-4347jweigelt@sjm.comMedia Relations:Kate Stoltenberg,
651-756-3388kstoltenberg@sjm.com
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