FDA Clears Philips' 3D TAVI Precision Treatment Planning Application

August 21, 2014—Royal Philips Electronics announced it has received 510(k) clearance from the US Food and Drug Administration to market its precision planning application for transcatheter aortic valve implantation (TAVI) treatments. The Philips TAVI application uses three-dimensional (3D) imaging to provide interventionists with preprocedural, high-precision positioning to treat aortic stenosis ailments. 

According to the company, the Philips TAVI planning application is available as part of the Philips IntelliSpace Portal 6, an advanced visualization and analysis solution that allows clinicians to access and analyze patient imaging and data nearly anywhere and at any time. The application features a comprehensive measurement package to accommodate virtually all types of TAVI devices. Advanced CT imaging allows the TAVI planning application to provide planes and panel measurements for precisely placing TAVI devices to manage the risk of under- or oversizing of a TAVI device. It renders images into a 3D heart model to allow interventionists to orient the device and address less-than-optimal patient cases.

The company advised that it will display the new TAVI application at the European Society of Cardiology’s ESC Congress 2014, held August 30 to September 3 in Barcelona, Spain.