MRA Imaging Agent Comparable to Traditional X-Ray Angiography Results
A new contrast-imaging agent for use with magnetic resonance angiography (MRA), ABLAVAR (gadofosveset trisodium), is indicated to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD).
In phase 3 clinical studies, ABLAVAR demonstrated statistically greater sensitivity (detecting disease when present) compared with non-contrast MRA. These studies, which supported the FDA approval of ABLAVAR, show that MRA images using ABLAVAR provided diagnostic accuracy comparable to conventional X-ray angiography. The advantages over X-ray angiography include a low dose injection, it does not require catheter insertion into a patient’s arteries, and does not expose patients to ionizing radiation.
The imaging agent was cleared by the FDA in 2009 and was launched on the U.S. market in January 2010.