St. Jude nets FDA clearance for cardiac imaging software

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has granted clearance for St. Jude Medical’s EnSite System-created chamber model with a 3D, CT model, allowing physician’s an improved view of the heart's anatomy to better 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 3-D, 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 previously obtained European CE Mark approval of the EnSite Fusion registration module.