Healthcare Industry News: electrophysiology
News Release - May 15, 2006
St. Jude Medical Announces FDA Clearance of EnSite(R) System 6 Software for Cardiac Mapping and Navigation
ST. PAUL, Minn.--(HSMN NewsFeed)--May 15, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance of the EnSite® System Version 6 software, which provides improved clinical capabilities for cardiac mapping and navigation during electrophysiology (EP) procedures.EnSite System Version 6 is designed to provide highly detailed, three-dimensional (3-D) cardiac models at the time of an EP procedure. Physicians create the 3-D model in small sections that join together automatically, resulting in a cardiac model that more accurately shows the openings, ridges and curves in the heart. The models are then used by physicians to collect information about the heart's electrical activity and assist them in diagnosing and treating many arrhythmias, including atrial fibrillation.
"The more accurate a cardiac model, the more useful it will be during an ablation procedure," said Vivek Reddy, M.D., of Massachusetts General Hospital in Boston. "The new capabilities of the EnSite System enable us to create a much more realistic representation of the anatomy than was previously possible, and to do it in as little as 10 minutes."
The new Version 6 software also includes an easier-to-use interface and other improvements that can help enhance the overall efficiency of EP procedures. Frequently used features are now easily accessible from the main screen, and images can now be displayed at full-screen size for greater visibility.
St. Jude Medical also has introduced new EnSite System software modules, including an advanced electrogram analysis tool that will support emerging approaches in the diagnosis and treatment of atrial fibrillation.
St. Jude Medical is the first company to offer remote technical support on a cardiac mapping system through its EnSite Connect(TM) Remote Support service. This new technology enables EnSite System users at hospitals worldwide to connect to a technical support team that can resolve issues in real time via a secure, broadband Internet connection.
"The EnSite System plays an important role in improving the understanding and treatment of complex arrhythmias such as atrial fibrillation," said Jane J. Song, president of St. Jude Medical's Atrial Fibrillation Division. "EnSite reflects improvements recommended by physicians. By working with the thought leaders in the field today we hope to develop the technologies that can help cure an increasing number of patients tomorrow."
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., the St. Jude Medical employs approximately 10,000 people worldwide. For more information, please visit www.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 success, regulatory approvals, anticipated future product launches, 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 the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and the cautionary statements described in the Company's Quarterly Report on Form 10-Q filed on May 9, 2006 (see pages 29-30). 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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