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FDA approves EPIX Pharmaceuticals’ blood vessel imaging system


LEXINGTON, Mass. The Food and Drug Administration has approved an agent for blood pool magnetic resonance angiography, a procedure for evaluating aortoiliac occlusive disease in adults.

EPIX Pharmaceuticals said Monday that the FDA had approved Vasovist (gadofosveset trisodium). AIOD occurs when iliac arteries become narrowed or blocked and may prevent the sufficient transport of oxygen or blood throughout the body.

EPIX said Vasovist is the first contrast agent approved for marketing in the United States for use with magnetic resonance angiography, a non-invasive way for imaging blood vessels. About 1.3 million MRA procedures were carried out in the United States last year.

“Vasovist is a first-in-class contrast agent with several unique characteristics that we believe will allow it to become a market leader in the United States,” EPIX interim CEO Elkan Gamzu said in a statement. “It offers good resolution angiography, a high signal per dose, a long imaging window timeframe and single-dose imaging of multiple vessel beds.”

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