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
May 14, 2025 
