FDA clears echo microbubble contrast agent
The FDA has approved Lumason, the microbubble contrast agent marketed by Bracco Diagnostics.
Lumason enables contrast-enhanced echocardiographic imaging and uses gas-filled microbubbles to reflect sound waves to enhance an image.
“Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret,” Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, said in a release. “Today’s approval provides doctors with another option when performing contrast-enhanced ultrasound.”
Lumason will carry a boxed warning about the risk of serious cardiopulmonary reactions, including fatal cardiac or respiratory arrest. These risks may be increased in those with certain heart conditions.