St. Jude Medical (St. Paul, Minnesota) reported FDA clearance of its EnSite Fusion Registration Module, new software designed to aid in creating detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including atrial fibrillation (AF).
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.
St. Jude said that 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, MD, 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 has CE-mark approval for the software. previously obtained European CE Mark approval of the EnSite Fusion Registration Module.
The company is featuring EnSite Fusion at this month’s Boston Atrial Fibrillation Symposium.