The Bracco Diagnostics has gained FDA approval for 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 recommended dose for both magnetic resonance imaging(MRI)of the central nervous system(CNS)and MRA examinations is 0.1mmol/kg(0.2ml/kg)of MultiHance.
Bracco Diagnostics Group Medical and Regulatory Affairs senior vice president Alberto Spinazzi said MultiHance has long been distinguished in the MRI of the CNS as a gadolinium-based contrast agent characterized by a strong increase in relaxivity in any medium containing serum proteins,contributing to increased contrast-to-noise ratio and lesion-to-brain ratio and improved visualization.
"The approval of MultiHance for use in MRA of renal and runoff arteries delivers to the radiologist a powerful tool,bringing the power of high relaxivity to the assessment and diagnosis of debilitating vascular diseases,"Spinazzi added.
MultiHance was the highest relaxivity gadolinium-based contrast agent available for intravenous use in MRI of the CNS in adults and paediatric patients.
The approval of MultiHance in MRA was based on data that demonstrated the safety and efficacy results from two large,prospective,multi-center clinical trials(one for each arterial vascular territory:renal and aorto-ilio-femoral).
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,according to Bracco.
