GE HealthCare has received FDA approval to expand the use of its Optison ultrasound enhancing agent (UEA) to pediatric patients, marking a new clinical indication for the polyethylene glycol-free contrast agent originally cleared for adults in 1997.

The Illinois-based company said the approval allows clinicians to use Optison to improve image clarity during echocardiography in children, particularly when standard ultrasound imaging produces insufficient detail to assess heart function accurately.

“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 Dr. Arash Sabati, pediatric cardiologist at Phoenix Children’s.
The approval follows results from a Phase IV, open-label multicenter study evaluating Optison’s ability to improve endocardial border definition and left ventricular visualization in pediatric patients. The findings showed improved diagnostic quality in patients with suboptimal echocardiogram images.

Optison, known generically as perflutren protein-type A microspheres injectable suspension, works by using microbubbles to enhance ultrasound signal reflection, improving the visibility of cardiac structures. Unlike other contrast agents, it does not contain polyethylene glycol (PEG), making it suitable for patients with PEG hypersensitivity.

“In some pediatric patients, standard echocardiography cannot produce sufficiently clear images of the heart, potentially hindering cardiologists’ ability to accurately diagnose underlying conditions,” said Dr. Jit Saini, chief medical officer of GE HealthCare’s pharmaceutical diagnostics segment.

Optison is currently indicated for patients with suboptimal echocardiograms. According to GE HealthCare, it has been administered to more than 5 million patients in the U.S.

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