Bracco Diagnostics announced that the FDA has approved the use of MultiHance (gadobenate dimeglumine) Injection, 529mg/mL, in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
The approval of MultiHance in MRA was granted based on data submitted to the FDA that included safety and efficacy results from two large, prospective, multi-center clinical trials (one for each arterial vascular territory: renal and aorto-ilio-femoral). Assessment of diagnostic efficacy for detecting/excluding clinically significant steno-occlusive disease (≥ 51% stenosis) was based on comparisons of sensitivity and specificity between MultiHance MRA and non-contrast MRA, with DSA as the standard of truth. Results of both trials showed a statistically significant increase in both sensitivity and specificity of MultiHance-enhanced MRA over non-contrast MRA in detecting clinically significant steno-occlusive disease.
MultiHance is also indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system in adults and children >2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.
For additional information call (609) 514-2200 or visit usa.braccoimaging.com.