FDA approves a new ultrasound imaging agent

For Immediate Release

October 10, 2014

Release

The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.

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 smooth edge on the inside of the chambers of the heart, known as the endocardium.

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

Lumason’s safety and efficacy were established in three clinical trials involving 191 patients 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 milliliter 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.

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 administration.

The most commonly reported side effects associated with Lumason were headache and nausea.

Lumason is marketed by Bracco Diagnostics Inc., located in Monroe Township, NJ.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.