Abstract
Vasovist ® (Gadofosveset) is the first intravascular contrast agent approved for use with magnetic resonance angiography in the European Union. This blood pool contrast agent reversibly binds to albumin providing extended intravascular enhancement compared to existing extracellular magnetic resonance contrast agents. Prior to approval, Vasovist ® underwent extensive clinical and pre-clinical 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 (aorto-iliac, renal, pedal), examination of potential drug interaction with warfarin, and comparison with X-ray angiography. 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. This review article highlights the product characteristics of Vasovist ®, gives an overview of the clinical development program and discusses selected clinical applications.
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