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.”
Leading Breast Radiologists Discuss the USPSTF Breast Cancer Screening Recommendations
May 17th 2024In recognition of National Women’s Health Month, Dana Bonaminio, MD, Amy Patel, MD, and Stacy Smith-Foley, MD, shared their thoughts and perspectives on the recently updated breast cancer screening recommendations from the United States Preventive Services Task Force (USPSTF).
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
Appealing Prior Authorization Denials: Can it be Effective for Emerging Technologies?
May 14th 2024While radiologists and other providers may be discouraged by insurer denials saying the use of a technological advance is “unproven and investigational,” 82 percent of appeals for prior authorization denials were approved in 2021.
Current Insights and Emerging Roles for Contrast-Enhanced Mammography
May 10th 2024In a recent lecture at the 2024 ARRS Annual Meeting, Jordana Phillips, MD, discussed the role of contrast-enhanced mammography in staging breast cancer, evaluating response to neoadjuvant chemotherapy and recalls from screening.