The U.S. Food and Drug Administration (FDA) has updated the indications for use of gadobutrol injection (Gadavist) in cardiac magnetic resonance (CMR) imaging to include assessing myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

The approval was based on two multinational, non-randomized, blinded-read Phase 3 studies of almost 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy. Gadobutrol was approved in 2011 and CMR is now the fourth FDA-approved indication. (View the list of FDA indications and usage.)

"Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial," said Daniel S. Berman, MD, FACC, chief of Cardiac Imaging and Nuclear Cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center, in a press release. "The FDA approval is a landmark for making this validated, non-invasive method available to health care professionals to evaluate their patients for the most common form of heart disease in the world."

Clinical Topics: Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD)

Keywords: ACC Advocacy, Gadolinium, Coronary Artery Disease, United States Food and Drug Administration, Organometallic Compounds, Cardiac Imaging Techniques, Heart Diseases, Cardiology, Magnetic Resonance Spectroscopy

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