The Food and Drug Administration (FDA) has approved Gadavist (gadobutrol; Bayer) injection for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
The approval was based on data from two phase 3 multicenter, open-label trials that evaluated the sensitivity and specificity of Gadavist cardiac MRI for detection of CAD in approximately 1000 adult patients with known or suspected CAD, of which 764 were evaluated for efficacy.
“We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour,” said Scott Flamm, MD, MBA, Head of Cardiovascular Imaging, Cleveland Clinic. “A Gadavist-enhanced cardiac MR is a key diagnostic tool, providing additional important clinical information, which can help physicians manage their patients with known or suspected CAD.”
Gadavist, a gadolinium-based contrast agent, is also indicated for use in MRI of the CNS in adults and children (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity; MRI of the breast to assess the presence and extent of malignant breast disease; and magnetic resonance angiography (MRA) in adults and children (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.
Gadavist is available in a 604.72mg/mL strength as 2mL, 7.5mL, 10mL, and 15mL single-dose vials and as 7.5mL, 10mL, and 15mL single-dose prefilled syringes.
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