Philips’ TAVI precision treatment planning application gets FDA 510(k) clearance

21 August 2014 (Last Updated August 21st, 2014 18:30)

Royal Philips has secured 510(k) clearance from the US Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments in the US.

Royal Philips has secured 510(k) clearance from the US Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments in the US.

The application is part of Philips IntelliSpace Portal 6 and provides interventionalists with pre-procedural, high-precision positioning to treat aortic stenosis ailments through three-dimensional (3D) imaging.

The application features a measurement package that accommodates all types of TAVI devices.

Philips Healthcare Imaging Systems CEO Gene Saragnese said: "As our population ages, minimally invasive TAVI procedures are becoming increasingly popular in the US, since they provide a non-surgical option for those patients who might have once been considered too high-risk for heart surgery.

"The application features a measurement package that accommodates all types of TAVI devices."

"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 also provides planes and panel measurements for easily placing TAVI devices to manage under or over sizing of the device.

Interventionalists can add the images into the 3D heart model to orient the device and address certain serious cases.

In 2011, the TAVI technology received FDA approval.

The TAVI technology, which came as a relief for high-risk patients who were considered non-surgical candidates, was found to reduce the mortality rate by 60%, when compared to conventional surgeries.

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