St. Jude Medical Announces FDA Clearance of EnSite Precision Cardiac Mapping System

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System enables faster, more accurate heart mapping during catheter
ablation to optimize treatment for patients with cardiac arrhythmias


ST. PAUL, Minn.–(BUSINESS WIRE)–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.

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.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C.
Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media
Relations:
Gina O’Connell, 651-756-3380
goconnell02@sjm.com