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

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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.

Contact information

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

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