FDA approves Bayer's Gadavist injection for MRA of supra-aortic arteries

Bayer announced this week that the FDA has approved its Gadavist (gadobutrol) injection for use with MR angiography for evaluating supra-aortic or renal artery disease.

FDA approved the contrast agent after the completion of two multi-center clinical studies, a Gadobutrol-Enhanced MRA of the Supra-aortic Vessels (GEMSAV) study and a Gadavist-Enhanced Renal Artery MRA study.

Elias Melhem, MD, chair of the department of diagnostic radiology & nuclear medicine at the University of Maryland and principal investigator of the GEMSAV study, said in a prepared statement that this approval from the FDA was historic.

“Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries,” Melhem said. “With FDA's action, radiologists now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack.”

Back in April, RadiologyBusiness.com reported on a new study that examined the allergic-like reaction rate of gadubutrol.