GE HealthCare said the FDA has approved a pediatric indication for the company’s Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA).
“In some pediatric patients, standard echocardiography cannot produce sufficiently clear images of the heart, potentially hindering cardiologists’ ability to accurately diagnose underlying conditions,” said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare. “This regulatory approval is a significant milestone that affirms the safety and efficacy of Optison in pediatric patients of all ages and expands our ability to offer this advanced imaging solution to a broader patient population. By facilitating more accurate measurement of left ventricular function, Optison enhances diagnostic capabilities, ultimately improving patient outcomes and providing greater value to healthcare providers and their patients.”
Optison contains gas-filled microbubbles that reflect ultrasound waves more effectively than surrounding tissues or blood, making the heart chambers and endocardial borders more visible, which is necessary for assessing heart conditions. Optison has a proven safety profile established over decades and is the only UEA available in the U.S. that does not contain polyethylene glycol (PEG). This allows it to be safely used by patients with PEG hypersensitivity, as PEG carries the potential to trigger anaphylaxis or hypersensitivity reactions in some patients.
Optison is currently indicated for use in patients with suboptimal echocardiograms. The FDA approved Optison for adults in 1997, and healthcare professionals have administered Optison to more than 5 million patients in the U.S. As the first of the second generation of UEAs to be approved by the FDA, the approval for the pediatric indication follows GE HealthCare’s Phase IV, prospective open-label multicenter study to evaluate the efficacy of Optison for contrast-enhanced echocardiograms in patients. The study found that the use of intravenous Optison optimized endocardial border delineation, improved the visualization of left ventricular wall segments and reduced the number of suboptimal echocardiogram images in pediatric patients.
