FDA Approves Bracco Diagnostics' Lumason Ultrasound Contrast Agent

October 10, 2014—The US Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound echocardiograms are hard to see with ultrasound waves. Lumason is marketed by Bracco Diagnostics Inc.

According to the FDA, Lumason is a contrast agent made up of gas-filled microbubbles (or microspheres) that reflect the sound waves to enhance the image. Lumason helps a physician see a patient’s heart more clearly, allowing for clearer imaging of the left ventricle chamber and the endocardium. 

In the announcement, Libero Marzella, MD, the director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, commented, “Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret. Today’s approval provides doctors with another option when performing contrast enhanced ultrasound.”

The FDA advised that Lumason’s safety and efficacy were established in three clinical trials involving 191patients with suspected cardiac disease whose echocardiograms were difficult to read and interpret. In all three studies, Lumason helped doctors see the lining of the left ventricle more clearly, with visual improvement observed in the majority of the patients who received a 2-mL dose of the agent. Lumason also helped independent reviewers in all three of the studies more clearly and completely see inside the patient’s left ventricle.

The agency noted that all microbubble contrast agents, including Lumason, carry a boxed warning about the risk of serious cardiopulmonary reactions, including fatal cardiac or respiratory arrest. The risk of these reactions may be increased among patients with certain heart conditions; most serious reactions occur within 30 minutes of administration. The most commonly reported side effects associated with Lumason were headache and nausea, stated the FDA.