The US Food and Drug Administration (FDA) has approved Bayer's Gadavist (gadobutrol) as the first and only contrast agent for use in cardiac magnetic resonance imaging (CMRI) in patients with coronary artery disease.
The injection has been approved to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
The approval is based on two prospective, open-label, non-randomised, multi-centre, blinded-read Phase III studies, which investigated the diagnostic results of gadobutrol-enhanced cardiac MRI for the evaluation of significant CAD.
Cardiac MRI is a medical imaging technology for the non-invasive assessment of the function and structure of the cardiovascular system, and the approval is a “landmark” for making the “validated, non-invasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world,” according to Daniel Berman, chief of cardiac imaging and nuclear cardiology at the Cedars-Sinai Heart Institute.
The technique is derived from and based on the same basic principles as MRI, however with optimisation for use in the cardiovascular system.
"This approval of the expanded use of Gadavist is important news for the 16.5 million people in the US affected by CAD because it offers them a very powerful and non-invasive diagnostic alternative”, said Thomas Balzer, head of Medical & Clinical Affairs Radiology at Bayer.
He continued, “As an industry leader in contrast media, we are dedicated to advancing science through innovation where it truly matters for patients. Using contrast-enhanced CMRI in patients with known or suspected CAD will provide cardiologists and radiologists with important information about the function of the heart muscle to support the management of patients with this highly prevalent disease.”
CAD is the most common type of heart disease in the United States, as up to one half of middle aged men and one third of middle aged women in the US are at risk of developing CAD during their lifetime.
It develops when the major blood vessels that supply the heart with blood, oxygen and nutrients (coronary arteries) become damaged or diseased, and plaque builds up in the arteries, decreasing blood flow to the heart.