Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA Regulatory

 News Release - May 8, 2007

St. Jude Medical Announces FDA Clearance and European Approvals for Cardiac Mapping and Navigation Software

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark for the EnSite(TM) System Version 7 software, and European CE Mark of the EnSite Fusion(TM) Registration Module. The new products will help physicians create more detailed images of the heart for navigating during electrophysiology (EP) procedures that treat complex arrhythmias.

The EnSite System provides highly detailed, three-dimensional (3-D) cardiac models that help physicians diagnose and treat many abnormal heart rhythms, including atrial fibrillation. Superior imaging results in better, faster care for patients and more reliable diagnostic tools for physicians.

St. Jude Medical's EnSite Fusion software registers, or "fuses," an EnSite-created geometry model with a three-dimensional CT (computed tomography, the current gold standard) model so that the physician can map directly on the CT image. The result is a 3-D, color, highly-detailed image of a chamber of the heart in which physicians can navigate EP catheters, display electrical information and effectively guide therapy delivery. EnSite Fusion allows physicians to use one system - EnSite - to produce state-of-the art imagery.

EnSite Fusion is the first and only registration tool with the capability to perform "dynamic registration." Dynamic registration matches the two models by creating anchor points on the EnSite images which are then linked to points on the 3-D model of the patient's CT. Fusing the geometric- and CT-derived models gives physicians a more detailed image of the heart to help them deliver ablation therapy.

The new Version 7 software's "field scaling" feature allows the system to compensate for impedance variations and improve the visualization of the heart's anatomy and EP catheters. EnSite 7 also includes new measurement tools which provide additional information about the size and location of key structures in the heart. Its detailed cardiac geometry gives physicians more data than ever before.

Carlo Pappone, M.D., Ph.D., of San Raffaele University Hospital in Milan, Italy, said, "This new software helps me create detailed, high-quality 3-D models of the heart's anatomy in just a few minutes, which greatly improves procedure efficacy and reduces the need for remote catheter manipulation."

The fusion tool also displays electrical information such as voltage, activation timing and lesion data directly on the CT model. In addition, EnSite Fusion provides the flexibility to transition quickly between the fused model and the original EnSite model throughout the procedure, helping clinicians react to changes in patient anatomy or other variations.

"EnSite Fusion makes the image even more realistic and provides an extremely detailed picture of the heart's anatomy," said Richard Schilling, M.D., of St. Bartholomew's Hospital in London. "I now can have a better diagnostic tool because two images - a CT image and the cardiac mapping image - are fused into one. Because everybody's heart is different, accuracy and precision are essential in diagnosis and treatment."

St. Jude Medical will feature EnSite(TM) System Version 7 and the EnSite Fusion(TM) Registration Module at the 2007 Heart Rhythm Society meeting in Denver, Colo., on May 9 through 12.

Heart Rhythm 2007 is the most comprehensive educational program for heart rhythm professionals, featuring over 200 educational sections and more than 130 innovative products and services. This year, the meeting will open with the AFib Summit, a two-day intensive summit on atrial fibrillation featuring world-renowned experts. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

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., St. Jude Medical employs more than 11,000 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 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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). 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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