St. Jude nets FDA clearance for cardiac imaging software
The FDA has granted clearance for St. Jude Medical’s EnSite System-created chamber model with a 3D CT model, allowing physicians an improved view of the heart's anatomy to guide the delivery of therapy.
The St. Paul, Minn.-based St. Jude said its new software allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a detailed image of the heart. Registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3D CT model, the company said.
EnSite Fusion also displays electrical information such as voltage, activation timing and lesion data directly on the CT model, St. Jude said.
The EnSite System is used in minimally invasive electrophysiology procedures, and St. Jude’s system has European CE Mark approval for the EnSite Fusion registration module.
The St. Paul, Minn.-based St. Jude said its new software allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a detailed image of the heart. Registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3D CT model, the company said.
EnSite Fusion also displays electrical information such as voltage, activation timing and lesion data directly on the CT model, St. Jude said.
The EnSite System is used in minimally invasive electrophysiology procedures, and St. Jude’s system has European CE Mark approval for the EnSite Fusion registration module.