FDA Clears Siemens' 3D Angiography Imaging Software for TAVR

February 16, 2012—Siemens Healthcare (Malvern, PA) announced that it received US Food and Drug Administration clearance for the Syngo Aortic ValveGuide, an integrated image processing software intended for preparation and performance of transcatheter aortic valve replacement. The software is now available in the United States.

The Syngo Aortic ValveGuide automatically reconstructs a three-dimensional (3D) representation of the aortic root from cross-sectional images acquired with angiography and provides the best projection angle for valve replacement. The software selects anatomical landmarks and overlays the 3D image with two-dimensional images acquired during live fluoroscopy. It calculates the exact perpendicular view of the aortic root, and the C-arm adjusts to the corresponding angulations for live fluoroscopy to provide real-time 3D guidance while navigating through the patient's anatomy and enabling precise positioning of the new valve.

The Syngo Aortic ValveGuide requires only a short fluoroscopy time, thereby reducing the patient's exposure to radiation and contrast. The Syngo Aortic ValveGuide uses Siemens' Syngo DynaCT Cardiac, which is software that processes computed tomography–like cardiac images from those acquired using angiography.

“Syngo DynaCT allows us to evaluate the anatomy of the aortic root and the position of the coronary ostia. The overlay of the intraprocedural 3D image over live fluoroscopy gives us an additional level of confidence for the valve implantation,” commented William O'Neill, MD. “The automated workflow of the Syngo Aortic ValveGuide makes the procedure easier, and the indication of a perpendicular view plane helps to make it even safer.”