St. Jude Medical Gets FDA Clearance for Cardiac Image Fusion Software

 

January 22, 2008

January 22, 2008 - The FDA cleared St. Jude Medical's EnSite Fusion Registration Module, software designed to help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including Atrial Fibrillation (AF), for use with minimally invasive electrophysiology procedures.

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. Catheters with electrodes are inserted into the cardiac chamber and then are located by the EnSite System, which records electrical information and creates a rendering of the chamber anatomy.

EnSite Fusion has dynamic registration, which allows for adjustments fusing the EnSite System-created and CT-derived models, engineered to provide 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 3D, 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.

For more information: www.sjm.com

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