The U.S. Food and Drug Administration approved Bracco Diagnostics' ($BDI) Lumason, a contrast agent used for patients whose echocardiogram images are difficult to see with ultrasound imaging.
The approval follows three clinical trials that involved 191 patients with suspected cardiac disease, and whose echocardiograms were difficult for doctors to see and interpret, the FDA said in a statement. In those studies, the use of Lumason made the lining of the left ventricle more clearly visible. Visual improvement was observed in the majority of the patients who received a 2-milliliter dose of the agent.
Lumason is a contrast agent made up of gas-filled microbubbles that reflect sound waves that enhance the image.
"Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret," Libero Marzella, the director 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."
Like all microbubble agents approved by the regulatory agency, Lumason must carry a boxed warning outlining the risks 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.