Gadofosveset is the first intravascular
contrast agent approved for use with magnetic resonance angiography in the European Union.
Gadofosveset reversibly binds to
albumin, providing extended intravascular enhancement beyond that of existing extracellular magnetic resonance
contrast agents. Prior to approval,
gadofosveset 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 (areas of turbulent blood flow, renal and pedal), examination of potential drug interaction with
warfarin and comparison with x-ray angiography. The clinical trials demonstrate that
gadofosveset-enhanced magentic resonance 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 noncontrast magnetic resonance angiography for the diagnosis of vascular
stenoses; and similar to conventional angiography for the overall characterization of
vascular disease, without the need for catheterization.