Vasovist (MS-325) is the first intravascular
contrast agent approved for use with magnetic resonance angiography in the European Union.
Vasovist reversibly binds to
albumin, providing extended intravascular enhancement compared to existing extracellular magnetic resonance
contrast agents. Prior to approval,
Vasovist underwent extensive testing to evaluate the safety and efficacy of the
drug; the clinical trials program included blinded, placebo-controlled dose ranging, efficacy in a variety of vascular beds (AIOD, renal, pedal), examination of potential drug interaction with
warfarin and comparison with XRA. The clinical trials show that
Vasovist-enhanced MR angiography is safe and well-tolerated in patients with
vascular disease, effective for the detection of vascular
stenosis and
aneurysms, significantly more accurate (both more sensitive and specific) than non-contrast MR angiography for the diagnosis of vascular
stenoses, and similar to conventional angiography for the overall characterization of
vascular disease, without the need for catheterization.