FDA Approves Pediatric Use of Ultrasound-Enhancing Agent in Suboptimal Echocardiogram Cases
A recent pediatric clinical trial revealed that left ventricular opacification with the ultrasound agent Definity improved ejection fraction assessment for 80 percent of patients.
The Food and Drug Administration (FDA) has granted approval for the use of the ultrasound contrast agent Definity (perflutren lipid microsphere) in pediatric patients with suboptimal echocardiograms.
Through opacification of the left ventricular chamber on ultrasound, Definity facilitates improved visualization of the left ventricular endocardial border, according to Lantheus, the manufacturer of Definity.
Lantheus noted the FDA approval was based on findings from three pediatric clinical trials. One study demonstrated enhanced detection of wall motion abnormalities in 70 percent of patients and improved determination of ejection fraction in 80 percent of patients.
"While (Definity) has long demonstrated its effectiveness in providing better outcomes in adults over the past two decades, this new FDA decision offers a critical diagnostic tool for pediatric heart patients and their families,” said Kassa Darge, M.D., Ph.D, radiologist-in-chief and chair of the Department of Radiology at Children’s Hospital of Philadelphia. “This approval will offer a valuable alternative to pediatric cardiologists trying to do imaging work up in challenging pediatric cardiac cases.”
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