Healthcare Industry News:  St. Jude Medical 

Devices Cardiology FDA

 News Release - September 14, 2009

St. Jude Medical Announces FDA Approval of EnSite Velocity Cardiac Mapping System

Next-generation cardiac mapping system gives physicians the ability to increase procedural efficiency and speed for treating irregular heart rhythms

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE: STJ ) today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of its EnSite Velocity(TM) Cardiac Mapping System. This new system has been designed to help physicians more efficiently diagnose and guide therapy to treat abnormal heart rhythms.

Advancements in the design of the EnSite Velocity System increase procedural efficiency and speed, making it easier to use from set-up and operation, to clinical application. With new hardware and software, the system offers simple set-up and connections, an intuitive software interface and includes two key new capabilities: the OneMap(TM) tool and RealReview(TM) function. The OneMap tool enables physicians to create a detailed cardiac model and electrical map together using multiple catheters and electrodes, allowing physicians to collect and display more relevant patient information in a shorter amount of time. The RealReview function provides real-time, side-by-side views of the live procedure and previously recorded portions of the procedure. This feature gives physicians a quick and easy comparison of events and results at different times throughout the procedure, without losing the ability to visualize and navigate catheters in real-time. The EnSite Velocity System is an open platform, which means that it is compatible with essentially all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures.

“We have been using the EnSite System for nearly ten years because of its ability to display and map electrical signals from multiple catheters and electrodes, and its convenience of being an open platform,” said Walid Saliba, M.D., of the Cleveland Clinic Foundation in Cleveland, Ohio. “The next-generation EnSite Velocity System also allows us to treat patients with any arrhythmia and navigate the heart with potential reduction in procedural time.”

The new EnSite Velocity System maintains the strengths and clinical utility that have made the EnSite(TM) System the leading cardiac mapping system, while incorporating significant improvements into the design. The EnSite Velocity System also continues EnSite’s longstanding ability to reduce fluoroscopy exposure and is the only mapping system capable of supporting both contact and non-contact mapping, giving the EnSite Velocity System unmatched versatility in its ability to map any arrhythmia.

“This system has exceptionally detailed chamber models and clear electroanatomical maps,” said Javier Sanchez, M.D., of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas. “Compared to other systems, I found the user interface to be very intuitive, quick and easy to learn.”

The EnSite Velocity System is used in minimally invasive electrophysiology procedures. Catheters with electrodes are inserted into a cardiac chamber; these electrodes are then located or visualized by the system, which records electrical information from the heart and displays it in a three-dimensional anatomical model. These highly detailed anatomical models, or maps, enable physicians to diagnose and guide therapy for abnormal heart rhythms. Like previous models of the EnSite System, the EnSite Velocity System allows catheter navigation to occur with reduced fluoroscopy, thus reducing potential for risks associated with excessive exposure to X-rays.

St. Jude Medical has been dedicated to finding a cure for AF for more than 15 years,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “As the next generation in cardiac navigation and visualization technology, the EnSite Velocity System is another demonstration of our company’s commitment to continuous innovation in meeting the needs of electrophysiologists.”

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 15,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009 and July 4, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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