Bracco Diagnostics has secured approval from the US Food and Drug Administration (FDA) for its Lumason contrast agent for use in ultrasonography of the urinary tract to assess suspected or known vesicoureteral reflux (VUR) in pediatric patients.
Lumason (sulfur hexafluoride lipid-type A microspheres) is claimed to be the first ultrasound contrast agent for use in voiding ultrasonography to evaluate VUR, which is a urinary tract abnormality in neonates, infants and children.
Globally known as SonoVue, Lumason was first approved October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border.
In March 2016, the Lumason secured FDA approval for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.
Lumason features gas-filled microspheres, which reflect the sound waves to enhance the echogenicity of the blood or urine, helping to improve the diagnostic quality of the ultrasound images.
According to the company, the contrast agent is packaged in a three-part portable kit that does not require refrigeration or mechanical agitation.
Each kit includes Lumason vial with 25mg of lipid-type A lyophilized powder and 60.7mg sulfur hexafluoride headspace, prefilled syringe with 5ml of Sodium Chloride 0.9% injection, USP (diluent) and mini-spike.
Bracco Group global medical and regulatory affairs head Dr Alberto Spinazzi said: "The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing neonates, infants and young children to the potential harmful effects of ionizing radiation.
"This approval reflects the efforts of Bracco to seek and provide new and expanded indications for this class of products working collaboratively with the FDA."