FDA Panel Okays New Ultrasound Imaging Agent 'Lumason'
The U.S. FDA panel gave a green signal to Lumason, a new ultrasound imaging agent that improves visibility of the heart that is difficult to see with ultrasound waves.
In a latest announcement, the U.S. Food and Drug Administration revealed the approval of Lumason (sulfur hexafluoride lipid microsphere) to be used on patients whose ultrasound images of the heart (echocardiograms) are difficult to view using the ultrasound waves. This newly released ultrasound imaging agent is a contrast agent that is made up of gas-filled microbubbles.
These microbubbles reflect the sound waves to improve the image of the echocardiogram. Lumason also helps physicians to clearly view the patients' heart allowing for the clearer imaging of the left ventricle chamber and the smooth edge on the inside of the chambers of the heart called as 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."
The researchers tested the safety and the efficacy of the agent in three different clinical trials that involved 191 patients who were suspected of having cardiac disease and whose echocardiograms the physicians found difficult to read and interpret.
In all the three studies, it was noticed that Lumason improved the visibility by allowing the doctors to clearly view the lining of the left ventricle. The visual improvement was seen in most of the patients who received a 2 milliliter dose of the agent.
Apart from this, the new ultrasound imaging agent helped independent reviewers in all three of the studies more clearly and completely view inside of the patient's left ventricle.
Similar to the other microbubble contrast agents, Lumason also comes with a boxed warning that cautions users about the risk of serious cardiopulmonary reactionsincluding fatal cardiac or respiratory arrest.
The risk of these reactions further increases in those with heart conditions, most serious reaction occurs within 30 minutes administration.
The most common side effects reported included headache and nausea. The new imaging agent is marketed by Bracco Diagnostics Inc..