(Reuters) - Bayer AG on Monday said U.S. regulators approved its contrast agent for use in magnetic resonance imaging (MRI) to assess patients with known or suspected coronary artery disease.
The injection, Gadavist, is an approved agent for use in MRI of the central nervous system and breasts. Contrast agents are used to make MRI scans easier to see.
Gadavist is the only contrast agent approved by the U.S. Food and Drug Administration for use in cardiac MR, an important diagnostic tool for patients with coronary artery disease (CAD), Bayer said.
The approval was based on two multinational late-stage studies of nearly 1,000 adults with suspected or known CAD based on signs and symptoms.
CAD develops when the major blood vessels that supply the heart with blood, oxygen and nutrients become damaged or diseased and affects about 16.5 million Americans, the company said.
Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber