Gadofosveset: the first intravascular contrast agent EU-approved for use with magnetic resonance angiography.

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.