Bayers Gadavist receives US FDA approval for use in cardiac MRI in patients with coronary artery disease
Bayer announced that the US FDA has approved Gadavist (gadobutrol) injection for use in cardiac magnetic resonance imaging (CMRI) to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). The FDA approval is based on two prospective, open-label, non-randomized, multi-center, blinded-read phase III studies, which investigated the diagnostic results of gadobutrol-enhanced cardiac MRI for the evaluation of significant CAD.
“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, Los Angeles, USA. “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.”