St. Jude Medical: begrensde marktvergunning EnSite Precision in Europa uitgebreid

ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc., een internationaal bedrijf in medische apparatuur, heeft vandaag bekendgemaakt dat de begrensde marktvergunning voor zijn cardiologische lokaliseringssysteem EnSite Precision in Europa is uitgebreid. Sinds het nieuwe platform in januari 2016 een CE-markering heeft gekregen, is het in negen landen zeshonderd keer toegepast. Het lokaliseringssysteem is ontworpen voor de automatisering en flexibilisering van zeer precieze behandelingen van patiënten die lijden aan een hartritmestoornis. De lancering gaat gepaard met de introductie van een compleet nieuwe reeks technologieën. Zo zijn er innovaties in hardware, catheters, elektrodes (patches) en software, die allemaal zijn ontworpen voor groter gebruiksgemak. Het systeem is in het kader van de initiële lancering momenteel beschikbaar in enkele Europese landen en breidt hier uit. Op dit moment ijvert het bedrijf voor een vergunning van de FDA voor het cardiologische lokaliseringssysteem EnSite Precision.

St. Jude Medical Announces New EnSite Precision Cardiac Mapping System Limited Market Release in Nine Countries Across Europe Since CE Mark

ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced expansion of its EnSite Precision™ cardiac mapping system limited market release in Europe and use of the new platform in more than 600 cases in nine countries since receiving CE Mark in January 2016. The mapping system is a next-generation platform designed to provide automation, flexibility and precision for tailored treatment in patients with cardiac arrhythmias. The launch constitutes introduction of an entirely new suite of technologies including innovations in hardware, catheters, surface electrodes (patches) and software features designed for improved ease of use. The system is currently available and expanding in select European countries as part of its initial launch and the company is currently pursuing U.S. Food and Drug Administration (FDA) clearance of the EnSite Precision cardiac mapping system.

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Now available in Europe, the St. Jude Medical(TM) EnSite Precision(TM) cardiac mapping system transforms procedures with intuitive automation, flexibility and precision (Photo: Business Wire).

The EnSite Precision cardiac mapping system is used in ablation procedures to visualize and navigate catheters in the heart. The system provides highly detailed anatomical models and maps to enable diagnosis of a wide range of arrhythmias, guide therapy and provide expanded procedural options to tailor care for patients. During this initial launch, the EnSite Precision cardiac mapping system was used in a variety of procedures, from simple to complex, including atypical flutter, paroxysmal and persistent atrial fibrillation (AF), and ventricular tachycardia (VT), with excellent system performance through challenging procedure dynamics.

“The EnSite Precision™ system is precise, reliable, accurate and it’s fast. This is very important when it comes to the demands of today’s electrophysiologists, especially as we see more patients with complex substrate based arrhythmias,” said Dr. Gerhard Hindricks, Director, Department of Electrophysiology, University of Leipzig Heart Center in Germany. “This is really what we need to push clinical electrophysiology forward to a better level of successful case execution.”

The EnSite Precision cardiac mapping system uses intelligent automation tools to enable faster, more accurate high-density maps with greater consistency across cases. The system is flexible and enhances efficiency by allowing physicians to map heart chambers with any electrophysiology catheter and customize procedures to address the circumstances of each case. The EnSite Precision cardiac mapping system allows catheter navigation to occur with less fluoroscopy, thus reducing potential for risks associated with excessive radiation exposure.

“We developed the EnSite Precision system with insight from world-renowned electrophysiologists to encompass leading mapping capabilities,” said Dr. Srijoy Mahapatra, vice president of clinical, medical and scientific affairs for St. Jude Medical. “Providing a best-in-class mapping system combining speed and detail with precision and stability allows physicians to have the information they need to treat both straightforward and complex 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. 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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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