MONROE TOWNSHIP, N.J., Jan. 12, 2017 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound contrast agent to obtain Food and Drug Administration (FDA) approval for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of suspected or known vesicoureteral reflux (VUR) in pediatric patients.

VUR is a urinary tract abnormality in neonates, infants and children characterized by retrograde flow of urine from the bladder into the ureter and toward the kidney and represents a common cause of recurrent urinary tract infections and chronic nephropathy in pediatric patients.1 Voiding cystourethrography and direct radionuclide cystography are the imaging procedures currently used to diagnose VUR in the U.S., and both require exposure to ionizing radiation.1

"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," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "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."

LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.

With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.2

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