Philips gets FDA nod for its TAVI Treatment Planning Application

The US regulator has approved Philips’ 3D planning software for Transcatheter Aortic Valve Implants (TAVI)


The Philips TAVI planning application is available as a part of Philips IntelliSpace Portal 6

Philips has announced that it has received the 510(k) clearance from the US Food and Drug Administration (US FDA) to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatment. Through 3D imaging, TAVI provides interventionalists with pre-procedural, high-precision positioning to treat aortic stenosis ailments.

The Philips TAVI planning application is available as a part of Philips IntelliSpace Portal 6-the company's advanced visualization and analysis solution that allows clinicians to access and analyse patient imaging and data virtually anywhere, at any time. The application features a comprehensive measurement package to accommodate, virtually, all types of TAVI devices.

"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," said Mr Gene Saragnese, CEO, Imaging Systems, Philips Healthcare. He added, "Treating cardiac conditions requires immense 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 upcoming ESC Congress 2014 where attendees can experience the Philips cardiology solutions first-hand, with a focus on the continuum of care, from prevention and diagnosis, to treatment, recovery, and wellness, delivering more efficient and effective cardiovascular care in the treatment of Coronary Artery Disease (CAD), Structural Heart Disease (SHD), and Heart Failure (HF).


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