The FDA approval of the FlexAbility catheter, which received CE Mark in Europe last year, further strengthens St. Jude Medical's fast-growing ablation technology portfolio and expands the ability of physicians to treat patients battling abnormal heart rhythms. The TactiCath™ Quartz contact-force sensing irrigated ablation catheter, approved and commercially available in Europe since 2012 and the U.S. since 2014, pioneered the ability to give physicians a real-time, objective measure of the force applied to the heart wall during a cardiac ablation procedure to treat paroxysmal atrial fibrillation (AF). The introduction of the FlexAbility catheter in the U.S. provides physicians with a best in class catheter for all their non-contact force cases. Combined, the technology offers physicians two new unique catheters that offer innovative solutions designed to improve outcomes, efficiency and productivity in electrophysiology labs worldwide.
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 ablation therapies. The FlexAbility ablation catheter was developed to be used seamlessly with St. Jude Medical's existing portfolio of electrophysiology products, including the EnSite™ Velocity™ System, the Ampere™ RF Generator and the Agilis™ NxT Steerable Introducer.
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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 December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2014. 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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