System enables faster, more accurate heart mapping during
catheter ablation to optimize treatment for patients with cardiac
arrhythmias
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced FDA clearance of its EnSite Precision™
cardiac mapping system and Advisor™ FL Circular Mapping Catheter,
Sensor Enabled™. The new EnSite Precision cardiac mapping system is
the latest addition to the company’s electrophysiology portfolio,
and is designed to provide automation, flexibility and precision in
cardiac mapping during the treatment of patients with abnormal
heart rhythms (cardiac arrhythmias). Prominent European
electrophysiology labs and hospitals have embraced this
next-generation platform, which has been used in thousands of cases
in Europe since receiving CE Mark in January 2016.
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When physicians use catheter ablation to treat abnormal heart
rhythm, a small area of heart tissue under the tip of the ablation
catheter is heated by high-frequency energy, creating a lesion or
tiny scar. As a result, this tissue is no longer capable of
conducting or sustaining the arrhythmia. Cardiac mapping provides a
live view of the heart so physicians can visualize and navigate
cardiac anatomy to deliver more precise ablation therapy. The new
EnSite Precision cardiac mapping system offers a new
dual-technology platform that provides highly detailed anatomical
models and maps to enable more efficient treatment of a wide range
of arrhythmias — including complex arrhythmias, such as atrial
fibrillation or ventricular tachycardia.
“The new EnSite Precision cardiac mapping system allows more
mapping data to be collected in a shorter amount of time compared
to today’s technologies,” said Dr. John Day, medical director of
the Intermountain Heart Rhythm Specialists at the Intermountain
Medical Center Heart Institute in Salt Lake City, who is set to
perform the first case in the United States. “We look forward to
implementing the EnSite Precision cardiac mapping system and the
new St. Jude Medical Sensor Enabled tools to help guide therapy and
provide expanded procedural options to tailor care for patients in
simple to complex ablation scenarios, as well as deliver a new
level of accuracy and speed in our procedures.”
The EnSite Precision cardiac mapping system is based on the St.
Jude Medical™ EnSite Velocity™ cardiac mapping system, which is
utilized in more than 2,000 electrophysiology labs around the
world. The EnSite Precision cardiac mapping system introduces new
solutions, including the EnSite™ AutoMap Module, which will enable
the electrophysiologist to more quickly perform morphology matching
that identifies the source of the irregular heartbeat using
automated cardiac rhythm mapping tools to facilitate treatment. The
EnSite AutoMap Module includes the new TurboMap feature, which will
allow the physician to build a map of the heart 10 times faster
than current systems using recorded data. St. Jude Medical expects
this technology to be a new standard for patients experiencing
arrhythmias from multiple origins in the heart.
“Our new EnSite Precision cardiac mapping system was designed to
give the physician a means to precisely navigate within the heart,
provide higher density diagnostic data to better inform their
diagnosis and allow them to use the tools that make sense for each
individual patient and situation,” said Dr. Srijoy Mahapatra, vice
president of clinical, medical and scientific affairs for St. Jude
Medical. “The system’s intelligent automation tools enable faster,
more accurate high-density maps with greater consistency across
cases, which are important factors in addressing the needs of
today’s EP labs.”
About EnSite Precision Cardiac Mapping System
The EnSite Precision cardiac mapping system is flexible and
enhances workflow efficiency by allowing physicians to map heart
chambers with any electrophysiology catheter and customize
procedures to address the circumstances of each case. The St. Jude
Medical EnSite Precision cardiac mapping system and the company’s
sensor enabled tools also allow catheter navigation to occur with
minimal fluoroscopy, thus reducing potential for risks associated
with excessive radiation exposure.
The launch of the EnSite Precision cardiac mapping system
includes other portfolio advancements that include new surface
electrodes (patches) and sensor-enabled mapping catheters. These
new tools along with the TactiCath™ Quartz contact force ablation
catheter are part of the company’s comprehensive EP portfolio to
help optimize clinical outcomes for treating arrhythmias.
About Cardiac Ablation
When physicians use catheter ablation to treat abnormal heart
rhythms (arrhythmias), several long, flexible tubes with wires —
called catheters — are inserted into the heart. Diagnostic
catheters record electrical information from the heart and display
it in a three-dimensional anatomical model, which is used to study
the abnormal rhythm.
Another catheter is used for the actual ablation. The doctor
positions the ablation catheter so it lies on or very close to the
targeted tissue. The small area of heart tissue under the tip of
the ablation catheter is heated by high-frequency energy, creating
a lesion or tiny scar. As a result, this tissue is no longer
capable of conducting or sustaining the arrhythmia.
About St. Jude Medical’s Electrophysiology (EP)
Business
St. Jude Medical’s electrophysiology (EP) business is one of the
fastest growing segments within St. Jude Medical’s portfolio.
The company’s EP product portfolio gives physicians the diagnostic,
access, mapping and therapy solutions they need with designed
integration for enhanced diagnosis and treatment of heart
arrhythmias. 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
ablation therapies. The EnSite Precision cardiac mapping system was
developed to be used seamlessly with the existing portfolio of St.
Jude Medical™ EP products, including the TactiCath Quartz Ablation
Catheter System, the FlexAbility™ Ablation Catheter, the Ampere™ RF
Generator and the Agilis™ NxT Steerable Introducer. For more
information about St. Jude Medical’s focus on arrhythmia
management, visit the St. Jude Medical Arrhythmias Media
Kit.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer
and is 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 five major areas of focus that
include heart failure, atrial fibrillation, neuromodulation,
traditional cardiac rhythm management, and cardiovascular. 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, reimbursement
strategies, 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 October 1, 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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version on businesswire.com: http://www.businesswire.com/news/home/20161215005212/en/
St. Jude Medical, Inc.Investor Relations:J.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia Relations:Gina O'Connell,
651-756-3380goconnell02@sjm.com
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