GE HealthCare has received approval from the US Food and Drug Administration (FDA) for a paediatric indication of its ultrasound enhancing agent, Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP).
The new indication aims to enhance the clarity and diagnostic precision of echocardiograms in children, enabling cardiologists to evaluate ventricular function better and identify potential heart conditions.
GE HealthCare’s Pharmaceutical Diagnostics chief medical officer Jit Saini said: “In some paediatric patients, standard echocardiography cannot produce sufficiently clear images of the heart, potentially hindering cardiologists’ ability to accurately diagnose underlying conditions.
“This regulatory approval is a significant milestone that affirms the safety and efficacy of Optison in paediatric 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 employs gas-filled microbubbles that reflect ultrasound waves more effectively than surrounding tissues or blood, thereby improving the visibility of heart chambers and endocardial borders.
Notably, Optison has a long-established safety profile and is the only ultrasound enhancing agent available in the US that does not contain polyethylene glycol (PEG), making it suitable for patients with PEG hypersensitivity, which can lead to severe allergic reactions.
Previously indicated for patients with suboptimal echocardiograms, Optison was first approved for adult use in 1997, and over five million patients in the US have received it since then.
The recent paediatric approval follows a Phase IV, prospective open-label multi-centre study conducted by GE HealthCare, which assessed the efficacy of Optison in contrast-enhanced echocardiograms for children.
The study demonstrated that intravenous Optison improved endocardial border delineation, enhanced the visualisation of left ventricular wall segments, and decreased the occurrence of suboptimal echocardiogram images in paediatric patients.
Earlier this month, GE HealthCare obtained FDA 510(k) clearance for its Aurora nuclear medicine system and Clarify DL. The advanced SPECT/CT solutions aim to improve diagnostic capabilities and optimise workflows, providing clinicians with enhanced image quality and increased operational efficiency.
