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Bracco Diagnostics Inc. announced on Friday that its ultrasound contrast agent — Lumason — received approval from the FDA. It's used for patients whose echocardiograms are difficult to view with ultrasound waves.
The agent is composed of gas-filled microbubbles that reflect the ultrasound waves in order to improve image quality. It gives the physician a clearer image of their patient's left ventricle chamber and the smooth edge of the inside of the chambers of the heart.
The agent was tested in three clinical trials in order to prove its safety and efficacy. The trials consisted of 191 patients who were suspected to have cardiac disease and whose echocardiograms were hard to interpret.
Lumason enabled the physicians to view the lining of the left ventricle more clearly in all three of the trials. It also helped independent viewers see the left ventricle more clearly in all of the trials.
"Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret," Dr. Libero Marzella, director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Today's approval provides doctors with another option when performing contrast enhanced ultrasound."
Lantheus Medical Imaging and GE Healthcare also have FDA approved ultrasound contrast agents on the market. All of the agents carry a warning due to the risk of serious cardiopulmonary reactions including fatal cardiac or respiratory arrest. For patients with certain heart conditions, the risk may be higher.
