Ultrasound Contrast Agent Market Grows with FDA Approval

October 13, 2014
Liza Haar

Lumason by Bracco Diagnostics is the latest ultrasound contrast agent to receive FDA approval.

The United States Food & Drug Administration (FDA) has approved the latest in a growing market of ultrasound contrast agents: Lumason by Bracco Diagnostics.

Lumason (sulfur hexafluoride lipid microbubbles) is indicated for better viewing of ultrasound images of the heart. The contrast agent is made up of gas-filled microbubbles (or microspheres) that reflect the sound waves to enhance the image, according to the FDA’s release. Lumason provides the physician with a clearer image of the patient’s left ventricle chamber and the smooth edge on the inside of the chambers of the heart, or the endocardium, the FDA said.

Lumason was evaluated in three clinical trials including 191 patients with suspected cardiac disease who had echocardiograms that were difficult to read or interpret. Lumason provided clearer images in all three trials, with visual improvement observed in the majority of patients who received a 2 milliliter dose of the agent.[[{"type":"media","view_mode":"media_crop","fid":"28417","attributes":{"alt":"Bracco logo","class":"media-image media-image-right","id":"media_crop_6420237765293","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2885","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 139px; width: 166px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":" ","typeof":"foaf:Image"}}]]

All microbubble contrast agents, including Lumason, carry a boxed warning about the risk of serious cardiopulmonary reactions, which may be increased among patients with certain heart conditions, the FDA said.

“Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret,” said Libero Marzella, MD, PhD, 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.”