GE Healthcare receives FDA indication approval for Visipaque injection for use with coronary CT angiography


GE Healthcare announced that it has received an indication approval from the FDA for its imaging agent Visipaque (iodixanol) Injection. Visipaque 320mg Iodine/mL is an iso-osmolar agent that is now approved for use in coronary computed tomography (CT) angiography to assist in the diagnostic evaluation of adult and paediatric patients 12 years of age or older with suspected coronary artery disease in the USA.

This new indication allows healthcare practitioners to image the coronary arteries of patients with suspected coronary artery disease, offering a non-invasive approach to diagnosis. With Visipaque’s CT angiography label extension, healthcare practitioners now have an FDA-approved contrast agent in such procedures that can be performed as an outpatient procedure when evaluating patients with suspected coronary artery disease.

Matt Budoff, professor of Medicine at UCLA (USA), says: “Coronary heart disease is a major cause of death in the USA. We are excited about the label extension of Visipaque as the first FDA approved iodinated contrast media for use in CT angiography.  Having an approved contrast agent for this modality may facilitate its use as a gatekeeper to invasive coronary angiography in patients with mild- to-moderate coronary artery disease, sparing patients from a more invasive procedure and long recovery times.”

The label extension approval for Visipaque 320mg Iodine/mL for CT angiography was evaluated in two prospective, multicentre clinical studies in a total of 1,106 adult patients. A press release reports that data from the two studies showed that Visipaque has a 99% negative predictive value in the diagnosis of coronary artery disease (study 1: sensitivity [76–89%], specificity [84–89%]; study 2: sensitivity (95%), specificity (87%).