The US Food and Drug Administration (FDA) has granted approval for the US-based subsidiary of Bracco Imaging, Bracco Diagnostics‘ Lumason for ultrasonography of the liver.
Globally known as SonoVue, Lumason received an FDA approval in 2014 to be administered in adult patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
The recent approval marks the ultrasound contrast agent as the first of its kind to be used for liver imaging and to be administered to children.
Bracco Group global medical and regulatory affairs senior vice-president Alberto Spinazzi said: “This new indication for Lumason reflects our efforts and investments to expand the range of approved clinical indications for contrast enhanced ultrasound in the US.
“We are very pleased with the collaborative work with the FDA whose review is critical to ensuring the safety and efficacy of any use of imaging products to the healthcare community.”
Lumason is a contrast agent utilised to enhance the sensitivity and classify malignant and benign focal hepatic lesions in the liver.
It is composed of gas-filled microspheres that echo sound waves to improve the image in ultrasonography.
Lumason is being used across more than 40 countries.
Last year, the centres for medicare and medicaid services issued a pass-through status for Lumason reimbursement, under the hospital outpatient prospective payment system (OPPS) according to which the contrast agent will be separately paid by Medicare for outpatient hospitals under OPPS.
The granting of FDA approval has been lauded by the International Contrast Ultrasound Society (ICUS) who had been advocating the wider acceptance and usage of ultrasound contrast agents.
Image: Image of apical thrombus generated by an ultrasound contrast agent. Photo: courtesy of Aurelia bregeras.