Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology Regulatory

 News Release - May 12, 2009

St. Jude Medical Announces European CE Mark Approval and First Use of Next-Generation Cardiac Mapping System

EnSite Velocity Cardiac Mapping System Increases Procedural Efficiency and Enhances Physician Ease of Use for Treating Irregular Heart Rhythms

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval and first use of its EnSite Velocity™ Cardiac Mapping System. This new system has been designed to help physicians more efficiently diagnose and deliver therapy to treat abnormal heart rhythms. St. Jude Medical will feature the EnSite Velocity System in booth #603 at the annual Heart Rhythm Society (HRS) Scientific Sessions, Heart Rhythm 2009.

Advancements in the EnSite Velocity System’s design are focused on increasing procedural efficiency, from set-up and operation, to clinical application and use. 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™ tool and RealReview™ function. The OneMap tool enables physicians to simultaneously create a detailed cardiac model and electrical map 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, giving 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 allows me to efficiently collect anatomical and mapping data with whichever catheter I believe is most appropriate for the procedure. The system’s versatility and catheter choice is important, providing me with enhanced control during the procedure,” said Tony Chow, M.D., of The Heart Hospital in London.

The new EnSite Velocity System maintains the strengths and clinical utility that have made the EnSite™ System the leading cardiac mapping system, while incorporating significant improvements into the design. The EnSite Velocity System continues its longstanding ability to visualize multiple catheters and electrodes 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. Additionally, 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.

“The EnSite Velocity System functions as though it were designed with the entire lab in mind; the simple setup and intuitive operation are incredibly helpful in supporting efficient procedural workflow,” said Christopher Piorkowski, M.D., of Herzzentrum Leipzig in Leipzig, Germany. “Because my practice has a fast-growing population of patients to serve, such efficiency gains benefit not only my patients but also other members of my team.”

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 deliver therapy for abnormal heart rhythms. Like previous models of the EnSite System, the EnSite Velocity System allows catheter navigation to occur without fluoroscopy, thus reducing potential for risks associated with excessive exposure to X-rays.

“The EnSite Velocity Cardiac Mapping System delivers the outstanding performance of the EnSite System, but with a new level of procedural efficiency,” 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 designed to integrate seamlessly with existing lab technology, while having built-in flexibility to allow for integration with future technologies.”

Heart Rhythm 2009 takes place May 13-16 at the Boston Exhibition and Convention Center. The meeting is the most comprehensive educational event on heart rhythm disorders, offering approximately 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including Cardiac Resynchronization Therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators.

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 approximately 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit

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 January 3, 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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