US FDA Approves First MR Angiography Contrast Agent for Supra-Aortic Arteries

The US Food and Drug Administration (FDA) approved the agent for use with Magnetic Resonance Angiography (MRA), based on the results of two clinical studies. The Phase 3 multi-center open-label studies included patients who were suspected of having, or know to suffer from vascular disease of the supra-aortic arteries, as well as patients with suspected or known renal artery disease.

The Bayer (Whippany, NJ, USA) Gadavist (gadobutrol) injection was used in the Gadavist-Enhanced MRA of the Supra-Aortic Vessels (GEMSAV) study that included 457 patients with suspected or known supra-aortic artery disease, and in the Gadavist-Enhanced Renal Artery MRA (GRAMS) study of 292 patients with suspected or known renal artery disease. In both studies gadobutrol was found to be able to visualize more vessel segments, and had non-inferior sensitivity and specificity compared to MRA without a contrast agent. The agent also showed significantly higher visualization compared to non-contrast MRA images.

Dr. Elias Melhem, MD, University of Maryland, and principal investigator for the GEMSAV study, said, "Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries. 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 (TIA)."

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