FDA Approved Bayer Gadavist Contrast Agent Contrast Agent
This decision is based on the data of two prospective multicenter open phase non-randomized blind clinical trials of the third phase, where diagnostic results of MRTT were studied using gadobutrol to assess significant coronary artery disease.
CMRT is a medical imaging technology for non-invasive evaluation of the function and structure of the cardiovascular system. Daniel Berman, Head of the Cardiac Imaging and Nuclear Cardiology Department of the Heart Institute of the Cedars-Sinai Medical Center, said that approval of the Gadavist contrast agent is an important step in creating a validated non-invasive method for assessing the condition of patients with the most common form of heart disease in the world.
This method is derived from MRI and uses the same basic principles as MRI, but is optimized for use in the diagnosis of diseases of the cardiovascular system.