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.
In Europe the HeartNavigator was already commercially introduced earlier this year. Now the Medical City Dallas Hospital, Dallas, Texas is the first hospital in the U.S. to use the HeartNavigator interventional tool in clinical practice.
Dr. Todd M. Dewey, MD, Cardiothoracic Surgeon at Medical City Dallas Hospital was cited in the Philips press release:
“After the recent commercial introduction of transcatheter heart valves in the U.S., we are now able to offer heart valve implantations to a group of patients for whom the risks associated with open heart surgery are too high. The implantation of a heart valve via a catheter has the advantage of being minimally invasive, but it demands high-quality imaging and precise navigation to ensure accurate positioning. HeartNavigator gives us a much better view of the procedure, which aids us in the preparation of the procedure as well as the execution.”
Press release: Philips announces FDA clearance and first commercial installation of its HeartNavigator interventional tool in the United States
Product page: HeartNavigator
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