Technology | CT Angiography (CTA) | June 16, 2017

FDA Adds Coronary CT Angiography Indication for GE Healthcare’s Visipaque Contrast Media

Visipaque is the first FDA-approved contrast agent indicated for non-invasive CCTA procedure 

GE Healthcares imaging agent Visipaque, iodixanol, is now cleared for use with cardiac CT angiography, CCTA

June 16, 2017 — The U.S. Food and Drug Administration (FDA) has expanded the indication for GE Healthcare’s imaging agent Visipaque (iodixanol) Injection. Visipaque 320 mg iodine/mL is an iso-osmolar agent that is now approved for use in coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of adult and pediatric patients 12 years of age or older with suspected coronary artery disease in the United States.

The new CCTA indication allows healthcare practitioners to image the coronary arteries of patients with suspected coronary artery disease (CAD), offering a non-invasive approach to diagnosis. Traditionally, radiologists and cardiologists have utilized invasive coronary angiography (ICA) procedures to diagnose potential CAD in patients, which can be costly and result in longer patient hospital stays. With Visipaque’s CCTA label extension, healthcare practitioners now have an FDA-approved contrast agent in CCTA procedures that can be performed as an outpatient procedure when evaluating patients with suspected CAD.
 
“Coronary heart disease is a major cause of death in the United States,” said Matt Budoff, M.D., FACC, director of cardiac CT and professor of medicine, Harbor-UCLA Medical Center, Torrance, Calif. “We are excited about the label extension of Visipaque as the first FDA approved iodinated contrast media for use in CCTA. Having an approved contrast agent for CCTA may facilitate the use of CCTA as a gatekeeper to ICA in patients with mild to moderate coronary artery disease, sparing patients from a more invasive procedure and long recovery times.”

Label extension approval for Visipaque 320 mg Iodine/mL for CCTA was evaluated in two prospective, multicenter clinical studies in a total of 1,106 adult patients. Data from the two studies showed that Visipaque has a 99 percent negative predictive value in the diagnosis of CAD (study 1: sensitivity (76-89 percent), specificity (84-89 percent); study 2: sensitivity (95 percent), specificity (87 percent))[1]. Visipaque’s label extension further enhances GE Healthcare’s cardiology portfolio, joining, Myoview, Adreview, and the recently announced distribution rights for Rapiscan outside the U.S. and Canada.

For more information: www3.gehealthcare.com/en/products/categories/contrast_media/visipaque

Related Content

Mednax National Cardiac Centers of Excellence Program Highlighted at SCCT 2019
News | CT Angiography (CTA) | July 11, 2019
Mednax Inc. and Mednax Radiology Solutions announced that Chief Medical Officer Ricardo C. Cury, M.D., FSCCT, will...
HeartFlow Planner Changes Treatment Strategy for Coronary Heart Disease Patients
News | CT Angiography (CTA) | May 28, 2019
New data demonstrated that use of the investigational HeartFlow Planner, a real-time, non-invasive interactive planning...
Siemens Somatom Force 64-slice, dual-source computed tomography (CT) system installed at the Baylor Scott & White Health Heart And Vascular Hospital.
360 Photos | CT Angiography (CTA) | May 20, 2019
This is a 360 degree photo of a Siemens Somatom Force 64-slice, dual-source computed tomography (CT) system installed
An example of a cardiac computed tomography angiography (CTA) perfusion exam showing iodine contrast mapping in the myocardium, which is used as a surrogate for blood perfusion.

An example of a cardiac computed tomography angiography (CTA) perfusion exam showing iodine contrast mapping in the myocardium, which is used as a surrogate for blood perfusion.

Podcast | CT Angiography (CTA) | May 03, 2019
A discussion with Gianluc...
How to reduce radiation dose in cardiac CT.
Feature | CT Angiography (CTA) | April 01, 2019 | Dave Fornell, Editor
April 1, 2019 — Here is a checklist of dose-sparing practices for coronary computed tomography angiography (CCTA) ima
CT Offers Non-Invasive Alternative for Complex Coronary Disease Treatment Planning based on data from the SYNTAX III Trial. The use of FFR-CT in the trial showed better planning for interventional procedures.

CT cffers a non-invasive alternative for complex coronary disease treatment planning based on data from the SYNTAX III Trial. 

News | CT Angiography (CTA) | October 16, 2018
A new study published in the European Heart Journal shows computed tomography (CT) can be a useful aid in heart team...
A comparison of CT image of heavily calcified coronary arteries that appear to present a significant hemodynamic blockages and the correspending FFR-CT showing the patient had adequate blood flow and does not need a diagnostic angiogram or intervention.

A comparison of a CT image of heavily calcified coronary arteries that appear to present a significant hemodynamic blockage and the corresponding FFR-CT showing the patient had adequate blood flow and does not need a diagnostic angiogram or intervention. Image courtesy of Kavitha Chinnaiyan, William Beaumont Hospital.

Feature | CT Angiography (CTA) | July 23, 2018 | Dave Fornell, Editor
The use of non-invasive fractional flow reserve CT (FFR-CT) was the hottest topic discussed at the...
Overlay Init