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St Jude Medical’s new cardiac imaging tool receives US FDA clearance

St Jude Medical : 17 January, 2008  (New Product)
The US Food and Drug Administration (FDA) has cleared St Jude Medical’s cardiac image integration software EnSite Fusion Registration Module.
The new software helps 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 optimise 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, MD, 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.
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