The US Food and Drug Administration (FDA) has approved the use of Bracco Diagnostics' 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.
The approval of MultiHance in MRA was based on data from two prospective, multicentre trials (one for each arterial vascular territory: renal and aorto-ilio-femoral), designed to assess 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.
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 two years of age, to visualise lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.
MultiHance of 0.1 mmol/kg (0.2 mL/kg) is the recommended dose for both MRI and MRA examinations, according to the company.
Dr. Alberto Spinazzi, Bracco Diagnostics medical and regulatory affairs group senior vice president, said MultiHance has long been distinguished in the MRI of the CNS as a GBCA, characterised 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 visualisation.
"It also counts a strong record of safety that spans [more than] 14 million administered doses," Spinazzi added.
"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."