Bayer announced Monday, July 15, that its Gadavist (gadobutrol) injection has been approved by the FDA for cardiac MR imaging to assess myocardial perfusion and late gadolinium enhancement in patients with suspected coronary artery disease (CAD).
The company noted in a prepared statement that Gadavist is the only contrast agent cleared by the FDA for cardiac MR. This is fourth FDA-approved indication overall for Gadavist.
“Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial,” Daniel S. Berman, MD, chief of cardiac imaging and nuclear cardiology at the Cedars-Sinai Heart Institute in Los Angeles and the S. Mark Taper Foundation Imaging Center in Hollywood, said 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.”
“We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour,” Scott Flamm, MD, MBA, head of cardiovascular imaging for the Cleveland Clinic, said in the same statement. “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.”