FDA approves pediatric indication for Optison ultrasound enhancing agent

On May 13, 2025, the FDA approved a pediatric indication for GE HealthCare's Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA), according to a press release from the company.¹ The federal agency's decision will allow for improved clarity and diagnostic accuracy of echocardiograms in pediatric patients to give cardiologists a "fuller picture of ventricular function when assessing possible heart abnormalities or disease," the company stated.

Officially, Optison is now indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricle to improve the delineation of the left ventricular endocardial borders.

First approved for adults in 1997, the UEA contains gas-filled microbubbles that reflect ultrasound waves compared to surrounding tissues or blood. This makes the heart chambers and endocardial borders more visible for assessing heart conditions. The UEA is used in more than 800 medical sites throughout the United States, and in 2021, the FDA removed the hypersensitivity to blood and blood products contraindication.²

The approval followed a phase 4, prospective, open-label, multicenter study from GE HealthCare that evaluated the efficacy of Optison for contrast-enhanced echocardiograms in patients. The study's results revealed that intravenous Optison optimized endocardial border delineation and improved visualization of the left ventricular wall segments. Additionally, Optison reduced the number of suboptimal echocardiogram images in pediatric patients.¹

“Ultrasound enhancing agents have significantly advanced diagnostic quality in adult echocardiography over the years, and we are now seeing promising research supporting their safe and effective use in pediatric patients,” said Arash Sabati, MD, FACC, in a statement. Sabati is a pediatric cardiologist and non-invasive imaging specialist at Phoenix Children's. “The availability of agents like Optison will further enhance diagnostic imaging for pediatric patients, helping to ensure the best possible care," added Sabati.

Optison is the only UEA available in the United States that does not contain polyethylene glycol (PEG). This allows for safe use among patients with PEG hypersensitivity, which has the potential to lead to anaphylaxis or hypersensitivity reactions in some patients.

"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, said Jit Saini, MD, chief medical officer of Pharmaceutical Diagnostics at GE HealthCare. "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 is contraindicated in patients with known or or suspected hypersensitivity to perflutren or albumin, and carries the following warning, courtesy of GE HealthCare.

Other warnings and precautions include:

• Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
• Serious anaphylactic reactions have been observed during or shortly following perflutren-containing microsphere administration, including shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products.
• When administering OPTISON to patients with a cardiac shunt, microspheres can bypass filtering of the lungs and enter the arterial circulation. Assess patients with shunts for embolic phenomena following OPTISON administration. OPTISON is only for intravenous administration; do not administer OPTISON by intra-arterial injection.
• High ultrasound mechanical index values may cause microsphere rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. OPTISON is not recommended for use at mechanical indices greater than 0.8.

Reference:

1. GE HealthCare announces FDA approval of pediatric indication for Optison ultrasound enhancing agent. GE HealthCare. Press release. May 13, 2025. Accessed May 13, 2025. https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-announces-fda-approval-of-pediatric-indication-for-optison-ultrasound-enhancing-agent

2. Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). GE HealthCare. Accessed May 13, 2025. https://www.gehealthcare.com/products/contrast-media/optison?srsltid=AfmBOoqe8UqDl3SaxrMD3urFqLNuEogMHdZFco31wC1EsydTFmGrft01