The U.S. Food and Drug Administration (FDA) has approved the Gadavist (gadobutrol) contrast agent for use in MR angiography (MRA) of known or suspected supra-aortic or renal artery disease, according to manufacturer Bayer HealthCare.
Before the decision, no contrast agent was approved for MRA of this region, said Dr. Elias Melham, chair of radiology at the University of Maryland. Melham was principal investigator of the Gadavist-Enhanced MRA of the Supra-Aortic Vessels (GEMSAV) study of patients with known or suspected vascular disease of the supra-aortic arteries.
In both the GEMSAV and Gadavist-Enhanced Renal Artery MRA (GRAMS) studies, the contrast agent met the primary objective of superior assessability and noninferior sensitivity and specificity as compared to noncontrast MR angiography, Bayer said.
