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Royal Philips Electronics N.V. (PHG) Gets FDA OK for 'Navigation' System for Heart Surgeons



12/22/2011 8:53:00 AM

After the recent introduction of transcatheter heart valves in the US, manufacturers are rushing to equip advanced cath labs with tools that will facilitate these complex procedures. Philips today announced FDA clearance of the HeartNavigator, a GPS-like tool that helps interventional cardiologists and cardiac surgeons to navigate during transcatheter aortic valve implantation (TAVI) procedures. It creates a 3D image from previously acquired 2D CT datasets. These 2D datasets are reconstructed and overlaid with live images to provide real-time 3D insights during the procedure. With one click, the heart is automatically segmented to visualize anatomical structures and landmarks. Virtual device templates can then be used to assess and select the appropriate device size and the best projection for the patient’s individual anatomy. The positioning of the catheter can be visualized in real-time together with the placement and deployment of the artificial valve.

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