FDA Approves Indication for GE Healthcare's Visipaque for Use With Coronary CT Angiography
May 2, 2017—GE Healthcare announced that it has received an indication approval from the US Food and Drug Administration (FDA) for its imaging agent Visipaque (iodixanol) injection.
The Visipaque 320-mg iodine/mL iso-osmolar agent is now approved for use in coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of adult and pediatric patients who are 12 years of age or older with suspected coronary artery disease (CAD) in the United States.
According to the company, the new CCTA indication provides a noninvasive approach for health care practitioners to image and diagnose the coronary arteries of patients with suspected CAD. With Visipaque’s CCTA label extension, a CCTA can be performed with an FDA- approved contrast agent in an outpatient procedure.
GE Healthcare advised that the 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% negative predictive value in the diagnosis of CAD (Study 1: sensitivity, 76-89%; specificity, 84-89%. Study 2: sensitivity, 95%; specificity, 87%).
In GE Healthcare's announcement, Matt Budoff, MD, commented, “Coronary heart disease is a major cause of death in the United States. 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.” Dr. Budoff is Professor of Medicine at David Geffen School of Medicine at UCLA in Los Angeles, California.