The FDA has approved Bayer’s gadobutrol (Gadavist) injection for use in cardiac MRI, making it the first contrast agent approved for the imaging technique, according to a statement from Bayer.
The contrast agent is used to assess myocardial perfusion and late gadolinium enhancement in patients with known or suspected coronary artery disease (CAD).
Its approval is primary based on the results of two multinational, non-randomized, blind-read phase III studies of nearly 1,000 patients with suspected or known CAD with signs and symptoms.
"Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial," said Daniel S. Berman, MD, chief of cardiac imaging and nuclear cardiology at the Cedars-Sinai Heart Institute in Los Angeles, in the statement. "The FDA approval is a landmark for making this validated, non-invasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world."
Gadavist received its first FDA approval back in 2011, making this most recent approval its fourth overall.
"We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour," said Scott Flamm, MD, MBA, head of cardiovascular imaging at the Cleveland Clinic. "A Gadavist-enhanced cardiac MR is a key diagnostic tool, providing additional important clinical information, which can help physicians manage their patients with known or suspected CAD."