The FDA approved Bracco Diagnostics’ Lumason agent for patients whose ultrasound image of the heart are hard to see with ultrasound waves.
Marketed in other countries as SonoVue, Lumason is a contrast agent made up of gas-filled microbubbles, or microspheres, that reflect sound waves to enhance the image. Lumason helps a physician see a patient’s heart more clearly, allowing for clearer imaging of the left ventricle chamber and the smooth edge on the inside of chambers, known as the endocardium.
Of an estimated 28 million echocardiograms administered annually in the U.S., 10% or more of those exams are reported as suboptimal and possibly inconclusive, according to statistics cited by Bracco.
"Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret," Dr. Libero Marzella of the FDA’s Center for Drug Evaluation & Research said in prepared remarks. "Today’s approval provides doctors with another option when performing contrast enhanced ultrasound."
Lumason’s safety and efficacy were established in 3 clinical trials involving nearly 200 patients with suspected cardiac disease whose echocardiograms were difficult to read and interpret. The most commonly reported side effects associated with Lumason were headache and nausea.
The FDA stated that all microbubble contrast agents, including Lumason’s sulfur hexafluoride lipid-type A microspheres, carry a boxed warning about the risk of serious cardiopulmonary reactions, including fatal cardiac or respiratory arrest. The risk of adverse reactions can increase for patients with certain heart conditions, with most serious reactions occurring within 30 minutes of administration.
Bracco Diagostics is located in Monroe Township, N.J., and is a subsidiary of Milan, Italy-based Bracco Imaging.
"We’re thrilled with the approval of Lumason as it represents a significant milestone in the company’s history," said Fulvio Renoldi Bracco, head of global business unit imaging at Bracco Imaging, in prepared remarks. "Today’s approval follows a long-term strategy of delivering the benefits of our contrast-enhanced ultrasound agent also in the U.S."