Technology | August 27, 2014

Philips Receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application

3-D model enables precision treatment for cardiac conditions in patients at high-risk for surgery

August 27, 2014 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its precision planning application for transcatheter aortic valve implantation (TAVI) treatments. Through 3-D imaging, the Philips TAVI application provides interventionalists with pre-procedural, high-precision positioning to treat aortic stenosis ailments. 

The Philips TAVI planning application is available as part of Philips IntelliSpace Portal 6, the company's advanced visualization and analysis solution that allows clinicians to access and analyze 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 Gene Saragnese, CEO, Imaging Systems, Philips Healthcare. "Treating cardiac conditions requires intense precision, and our TAVI planning application delivers a solution for aortic device placement to help improve patient care."

Through advanced computed tomography (CT) imaging, the TAVI planning application provides 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 3-D heart model to allow interventionalists to orient the device and address less-than-optimal patient cases.

The TAVI technology received FDA approval in 2011. A minimally invasive procedure, TAVI became a major breakthrough option for high-risk patients who were deemed non-surgical candidates. This procedure can reduce mortality by 60 percent as compared to conventional surgeries.

The Philips TAVI application will be on display at the upcoming European Society of Cardiology (ESC) Congress 2014.

For more information: www.usa.philips.com/healthcare

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Hitachi Supria True64 CT Receives FDA Clearance
Technology | Computed Tomography (CT)| September 15, 2017
Hitachi Healthcare Americas Inc. announced it has attained U.S. Food and Drug Administration (FDA) 510(k) clearance to...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Overlay Init