A leading global diagnostic imaging company has announced US FDA approval of injectable contrast agent for the characterization of focal liver lesions, using ultrasonography of the liver.
The US Food and Drug Administration (FDA; Silver Spring, MD USA) approved the contrast agent, “sulfur hexafluoride lipid-type A microspheres,” for use in adults with suboptimal echocardiograms, and also for children. This is the first ultrasound contrast agent approved by US FDA approval for use in liver imaging, and the first one approved for pediatric patients. The agent improves the sensitivity, and specificity of ultrasonography, and helps surgeons differentiate between focal hepatic lesions that are benign and those that are malignant.
The LUMASON agent, also called SonoVue, was developed by Bracco Imaging (Monroe Township, NJ, USA), and is already being used in Europe and Asia. The agent consists of gas-filled microspheres which reflect sound waves, and enhance the ultrasonographic images. The system has a proven safety, and efficacy profile for liver ultrasonography, and echocardiography, and is packaged in a three-part kit that does not need mechanical agitation, or refrigeration.
Alberto Spinazzi, MD, senior VP, global medical and regulatory affairs, in the Bracco group, said, “We are proud to be the first company to obtain FDA approval for this important clinical use of ultrasound contrast both in adults and children. This new indication for LUMASON reflects our efforts and investments to expand the range of approved clinical indications for contrast enhanced ultrasound in the United States. We are very pleased with the collaborative work with the FDA whose review is critical to ensuring the safety and efficacy of any use of imaging products to the healthcare community.”