Royal Philips announced yesterday that its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments received FDA 510(k) clearance. The application helps interventionalists achieve high-precision positioning to treat aortic stenosis ailments.

The application is part of IntelliSpace Portal 6, which is Philips' advanced visualization and analysis solution that lets physicians access and analyze patients' imaging and data at any location.

The application is used in conjunction with CT imaging and it generates planes and panel measurements in order to place the TAVI devices with precision and avoid under or oversizing the devices. It then converts the images into a 3-D heart model.
The TAVI technology was approved by the FDA in 2011 and it has proved itself to be very useful for patients who are at high-risk and are unable to undergo invasive surgery. It can reduce mortality by 60 percent compared to traditional surgeries, according to a study conducted by The PARTNER Trial Investigators.

"As our population ages, minimally invasive TAVI procedures are becoming increasingly popular in the United States, since they provide a non-surgical option for those patients who might have once been considered too high-risk for heart surgery," Gene Saragnese, CEO of Imaging Systems at Philips Healthcare, said in a statement. "Treating cardiac conditions requires intense precision and our TAVI planning application delivers a solution for aortic device placement to help improve patient care."

The application will be displayed at the European Society of Cardiology Congress 2014 from August 30 to September 3.

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