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

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 Society of Cardiov
Videos | CT Angiography (CTA) | July 19, 2018
Kavitha Chinnaiyan, M.D., FACC, FSCCT, associate professor, Oakland University, William Beaumont School of Medicine,
Videos | CT Angiography (CTA) | July 18, 2018
A discussion with Gianluca Pontone, M.D., Ph.D., FSCCT, director of cardiovascular MRI, Centro Cardiologico Manzino,
Videos | CT Angiography (CTA) | July 17, 2018
A discussion with Todd Villines, M.D., FACC, FAHA, FSCCT, cardiologist, Georgetown Medical Center, and president of t
HeartFlow Announces New Commercial Coverage With UnitedHealthcare
News | CT Angiography (CTA) | July 03, 2018
HeartFlow Inc. announced that UnitedHealthcare now covers the HeartFlow FFRct Analysis, extending access to their 45...
Post-Mortem CT Angiography Illuminates Causes of Death
News | CT Angiography (CTA) | June 25, 2018
Computed tomography (CT) angiography is a useful adjunct to autopsy that is likely to increase the quality of post-...
iSchemaView Receives FDA Clearance for Rapid CTA
Technology | CT Angiography (CTA) | May 01, 2018
Cerebrovascular imaging analysis company iSchemaView received final clearance from the U.S. Food and Drug...
The use of metal artifact reduction software on this CCTA (CTA) cardiac CT from an Canon, Toshiba, Aquilion Precision, allows clear visualization inside a coronary stent. The 0.25 mm high-resolution reconstruction also helps delineate the various components of plaque.

The use of metal artifact reduction software on this Aquilion Precision image allows clear visualization inside a coronary stent. The 0.25 mm high-resolution reconstruction also helps delineate the various components of plaque.

Feature | CT Angiography (CTA) | April 26, 2018 | Dave Fornell
There have been a few big, recent advancements in cardiac computed tomography angiography (CCTA) imaging technology.
Siemens Healthineers, Florida Hospital Collaborate to Improve Healthcare Outcomes
News | CT Angiography (CTA) | January 23, 2018
January 23, 2018 – Siemens Healthineers and Florida Hospital, part of Adventist Health System, have announced a multi
Overlay Init