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EnSite 3-D cardiac modelling system is cleared for US and Europe

St Jude Medical : 09 May, 2007  (New Product)
US FDA clearance and European CE Mark approval has been granted for St Jude Medical's EnSite System Version 7 software, and the EnSite Fusion 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, colour, 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 visualisation 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, MD, PhD, 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 MD 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 System Version 7 and the EnSite Fusion Registration Module at the 2007 Heart Rhythm Society meeting in Denver, Colorado, USA, on 9 to 12 May 2007.

Heart Rhythm 2007 is the most comprehensive educational programme 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.
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