St. Jude Medical Announces U.S. Clearance For Cardiac Image Integration Software

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals;  MRI / PET / Ultrasound
Article Date: 17 Jan 2008 - 3:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) clearance for its EnSite Fusion(TM) Registration Module. The new software will help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including Atrial Fibrillation (AF).

St. Jude Medical's EnSite Fusion software registers, or integrates, an EnSite System-created chamber model with a three-dimensional computed tomography (CT) model so that the physician has an improved view of the heart's anatomy to better guide the delivery of therapy.

EnSite Fusion is the first and only tool with the capability for "dynamic registration," which allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a more detailed image of the heart. Dynamic registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3-D, CT model.

EnSite Fusion 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 optimize the view to best meet the specific demands of the procedure.

"The models produced by EnSite Fusion result in better, faster care for my patients and more reliable delivery of therapy for complex arrhythmias, such as atrial fibrillation," said Andrea Natale, M.D., who is a consulting professor at Stanford University and practicing at California Pacific Medical Center. "Because each heart is different, having a tool that helps guide the direction of the therapy through the detailed models is of great value to me."

The EnSite System is used in minimally invasive electrophysiology procedures. Catheters with electrodes are inserted into the cardiac chamber and then are located or "sensed" by the EnSite System, which records electrical information and creates a rendering of the chamber anatomy.

St. Jude Medical previously obtained European CE Mark approval of the EnSite Fusion Registration Module.

St. Jude Medical will feature EnSite Fusion at the Boston Atrial Fibrillation Symposium, which begins tomorrow and is a meeting of leading electrophysiologists in the field of arrhythmia and atrial fibrillation (AF) management from around the world. The meeting ends January 19, 2008.

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 approximately 12,000 people worldwide.

St. Jude Medical

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 pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical

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