FDA approves new agent for contrast-enhanced echocardiograms

The FDA has approved sulfur hexafluoride lipid microsphere as a contrast agent for patients undergoing echocardiograms.

According to a press release, sulfur hexaflouoride lipid microsphere, or Lumason (Bracco Diagnostics Inc.), consists of gas-filled microbubbles that reflect sound waves. The agent is intended to improve visibility of the left ventricle chamber and the endocardium during echocardiograms.

“Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret,” Libero Marzella, MD, PhD, director of the division of medical imaging products at the FDA Center for Drug Evaluation and Research, said in the release. “Today’s approval provides doctors with another option when performing contrast-enhanced ultrasound.”

The approval follows results from three clinical trials that included a total of 191 patients with suspected cardiac disease and difficult-to-interpret echocardiogram data. According to the release, the majority of patients who received 2 mm of Lumason had improved visualization of the left ventricle on subsequent echocardiograms.

Lumason, like other microbubble contrast agents, will include a boxed warning about risks for serious cardiopulmonary reactions, including fatal cardiac or respiratory arrest, particularly among patients with certain heart conditions, according to the release. Commonly observed adverse events linked to the agent included headache and nausea.