Bracco Diagnostics has obtained the US Food and Drug Administration (FDA) clearance for use of its MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, in magnetic resonance angiography (MRA), designed to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
Previously, MultiHance was approved as gadolinium-based contrast agent (GBCA) for intravenous use in magnetic resonance imaging (MRI) of the central nervous system in adults and children over 2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.
The company said 0.1 mmol/kg (0.2 mL/kg) of MultiHance is the recommended dose for both MRI and MRA examinations.
The approval of MultiHance in MRA was based on data from two prospective, multi-center trials (one for each arterial vascular territory: renal and aorto-ilio-femoral), designed to asses the safety and efficacy of MultiHance.
The diagnostic efficacy for detecting/excluding clinically significant steno-occlusive disease (= 51% stenosis) was assessed based on comparing sensitivity and specificity between MultiHance MRA and non-contrast MRA, with DSA as the standard.
Results of the trials demonstrated significant increase in both sensitivity and specificity of MultiHance-enhanced MRA over non-contrast MRA in detecting clinically significant steno-occlusive disease.
Bracco Diagnostics medical and regulatory affairs group senior vice president Dr. Alberto Spinazzi said MultiHance has long been distinguished in the MRI of the CNS as a GBCA 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.
"It also counts a strong record of safety that spans over 14 million administered doses," Spinazzi added.