Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux.
“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,” head of global medical and regulatory affairs Dr. Alberto Spinazzi said in prepared remarks. “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.”
The gas-filled microspheres reflect sound waves to enhance the echogenicity of the blood and urine, improving the diagnostic quality of ultrasound images, according to the Monroe Township, N.J.-based company.
Vesicoureteral reflux is a urinary tract abnormality in pediatric patients, characterized by the backwards flow of urine from the bladder into the kidney. Currently, voiding cystourethrography and direct radionuclide cystography are used to diagnose the condition, and both imaging procedures require exposure to ionizing radiation.
Lumason was initially approved by the FDA in October 2014 for use in adults with suboptimal echocardiograms. In March last year, Lumason was approved for use in ultrasonography of the liver in adult and pediatric patients to characterize of focal liver lesions