Vasovist approved to evaluate aortoiliac occlusive disease
The FDA has approved Vasovist (gadofosveset trisodium, from EPIX), a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease. This approval was based on a blinded, independent re-read of images from a previous Phase 3 study. Vasovist was found to have more accurately detected disease when disease was present or exclude disease if it wasn't present at a rate that was not worse than non-contrast MRA. Additionally, Vasovist demonstrated significantly better sensitivity and specificity than chance alone.
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