The U.S. Food and Drug Administration (FDA) has approved a pediatric indication for GE HealthCare’s (GEHC’s) Optison ultrasound enhancing agent.
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) contains gas-filled microbubbles that reflect ultrasound waves more effectively than surrounding tissues or blood to improve visibility of the heart chambers and endocardial borders for assessing and diagnosing heart conditions. Optison does not contain polyethylene glycol (PEG), which allows it to be safely used by patients with PEG hypersensitivity, GEHC said.
Optison, which was approved by the FDA for adult use in 1997, is currently indicated for patients with suboptimal echocardiograms.
In a statement, GEHC noted that the FDA approval for Optison’s pediatric use follows GEHC’s Phase IV, prospective open-label multicenter study to evaluate the efficacy of Optison for contrast-enhanced echocardiograms. The study found that the use of intravenous Optison improved endocardial border delineation, visualization of left ventricular wall segments, and reduced the number of suboptimal echocardiogram images in pediatric patients.
