FDA Approves Ultrasound Enhancing Agent for Use in Pediatric Patients

Officials with the FDA have approved sulfur hexafluoride lipid-type A microspheres for injectable suspension (Lumason, Bracco Diagnostics Inc), for use in echocardiography in pediatric patients. This is the drug’s fourth indication approved by the FDA.

The contrast agent is newly indicated to opacify the left ventricular chamber, and to improve the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms. It also is indicated for the same use in adult patients. In addition, sulfur hexafluoride lipid-type A microspheres for injectable suspension is indicated for ultrasonography of the liver for characterization of focal liver lesions in adults and children, as well as in ultrasonography of the urinary tract for the evaluation of pediatric patients with vesicoureteral reflux.

This is the first ultrasound enhancing agent to receive FDA approval for this use in pediatric patients. It is comprised of gas-filled microspheres which enhance the ability to bounce an echo off of blood or urine. The microspheres reflect sound waves resulting in an improvement in the diagnostic quality of the ultrasound images.

Sulfur hexafluoride lipid-type A microspheres for injectable suspension has been distributed outside the US since 2001 under the name SonoVue. It was initially approved in October 2014 for use in adults with suboptimal echocardiograms.

The agent received “pass-through” status for reimbursement from the Centers for Medicare and Medicaid Services in late 2015 under the Hospital Outpatient Prospective Payment System. Sulfur hexafluoride lipid-type A microspheres for injectable suspension is currently the only ultrasound enhancing agent with this additional payment due to its technology designation, according to Bracco Diagnostics.

Serious cardiopulmonary reactions have occurred during or after the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. The risk for serious reactions may increase among patients with unstable cardiopulmonary conditions, such as acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias. The most common adverse reactions observed with this injectable suspension are headache and nausea.

REFERENCE

Bracco Diagnostics Inc.’s LUMASON receives US Food and Drug Administration approval for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in pediatric patients [news release]. Monroe Township, NJ; December 2, 2019: Bracco Diagnostic Inc. https://imaging.bracco.com/us-en/bracco-diagnostics-inc-s-lumason-receives-us-food-and-drug-administration-approval-use. Accessed December 2, 2019.