FDA Approves Myocardial Perfusion Indication for MR Contrast Agent Gadobutrol (Gadavist)


July 15, 2019

The US Food and Drug Administration has approved the gadolinium-based magnetic-resonance (MR) imaging contrast agent gadobutrol (Gadavist/Gadovist, Bayer) for myocardial perfusion studies in adults with known or suspected coronary artery disease (CAD), Bayer announced today.

"Gadavist is now the first and only contrast agent FDA approved for use in cardiac MR," the company said in a press release, which notes the agent has been available in the United States since 2011 for other indications, including  known or suspected supra-aortic or renal artery disease in adults and children, some neurovascular applications, and adults with breast cancer.

The company's press release also quotes two cardiac MR experts who coauthored a recent consensus statement on using the imaging method for myocardial perfusion studies.

In the release, Daniel S. Berman, MD, of Cedars-Sinai Heart Institute, Los Angeles, California, touted the clinical trial support for "gadobutrol-enhanced cardiac MR."

And Scott Flamm, MD, MBA, Cleveland Clinic, Ohio, is quoted: "We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than 1 hour."

FDA has approved Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease.

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