The Food and Drug Administration (FDA) has approved Lumason (sulfur hexafluoride lipid-type A microspheres; Bracco Diagnostics Inc.), an ultrasound enhancing agent, for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms. Previously, the treatment was only approved for use in adult patients.
The approval was based on data from a prospective multicenter trial that evaluated Lumason 0.03mL/kg in 12 pediatric patients aged 9 to 17 years with suspected cardiac disease and suboptimal non-contrast echocardiography. Results of the study showed an improvement in left ventricular endocardial border delineation. In addition, complete left ventricular opacification was observed in all patients by all 3 independent reviewers following administration of Lumason. With regard to safety, no new adverse reactions were identified in pediatric patients.
Lumason is supplied as a kit containing 1 vial of 25mg lyophilized powder, a prefilled syringe with 5mL Sodium Chloride 0.9%, and a Mini-Spike. After reconstitution, it is administered via intravenous injection during echocardiography.
“The FDA approval of Lumason ultrasound enhancing agent for use in pediatric patients further supports the efficacy and safety profile of this agent in echocardiography and confirms its positive risk-benefit ratio, even when used in special and vulnerable populations,” stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group.
Lumason is comprised of gas-filled microspheres that reflect an ultrasound signal that provides a visual image that shows a contrast between blood or urine and the surrounding tissues. It is also indicated for use in ultrasonography of the liver to characterize focal liver lesions in adult and pediatric patients, and for use in ultrasonography of the urinary tract for evaluation of suspected or known vesicoureteral reflux in pediatric patients.
For more information visit braccoimaging.com.
This article originally appeared on MPR