GE HealthCare Wins Pediatric FDA Nod for Optison Ultrasound Enhancing Agent

GE HealthCare has earned U.S. Food and Drug Administration (FDA) approval for a pediatric indication of its Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA).

The company said the approval will boost echocardiogram clarity and diagnostic accuracy in pediatric patients. This will provide cardiologists a fuller picture of ventricular function when evaluating potential heart abnormalities or disease.

Optison has gas-filled microbubbles that reflect ultrasound waves more effectively than tissues or blood, GE HealthCare said. This makes the heart chambers and endocardial borders more visible.

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It also has a safety profile established over decades and is the only UEA in the U.S. that doesn’t contain polyethylene glycol (PEG). This means patients with PEG sensitivity can use it—PEG can trigger anaphylaxis or hypersensitivity reactions in some patients.

Currently indicated for patients with suboptimal echocardiograms, Optison was FDA approved for adults in 1997. The approval for a pediatric indication is the first of the second generation of UEAs to be approved by the agency. It follows the company’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.

“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, 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.”

“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.”

Yesterday the company revealed its Signa Sprint MRI scanner, an FDA 510(k)-pending, wide-bore, 1.5T high-performance gradient MRI system.