Despite advancements in echocardiography, imaging can be suboptimal, which may lead to inadequate treatment plans, unnecessary additional testing, increased hospital stays and avoidable hospital readmissions. Now, the most utilized, extensively studied, and trusted diagnostic ultrasound enhancing agent in the U.S. can now also address the unmet medical needs of pediatric patients.

Lantheus Holdings (Bedford, MA, USA) has received the U.S. Food and Drug Administration (FDA) approval for its supplemental new drug application (sNDA) for DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval provides healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border, marking a significant step forward in pediatric medicine. The FDA decision was based on usage data from three pediatric clinical trials involving DEFINITY: the Golding study, which assessed 40 patients aged between 1 month and 17 years with significant heart conditions, such as heart transplants, Kawasaki disease, or congenital cardiovascular anomalies; the Fine study, which looked at 36 individuals aged between 10 to 21 years who had previously had a heart transplant; and the Kutty study, which was a retrospective review of medical records for 113 pediatric patients aged 5 to 21 years diagnosed with or suspected of having congenital or acquired heart disease. A total of 189 patients were evaluated in these studies, with 107 (56.5%) being male and 82 (43.5%) female.

The data from the Golding study, along with additional insights from the Fine and Kutty studies, show that DEFINITY can successfully enhance the left ventricular opacification in children at cumulative doses ranging from 6 µL/kg to 20 µL/kg, and that ultrasound contrast is vital for managing such patients. In the Golding study, enhancements were seen in detecting wall motion abnormalities and in performing ejection fraction determinations for the majority of subjects (70% and 80%, respectively). The Kutty and Fine studies both reported successful enhancement of the left ventricular chamber in all participants. Specifically, the Kutty study found wall motion or myocardial perfusion abnormalities in 13 (11.5%) patients, all identified during stress tests, and an increase in the average number of left ventricular segments visualized from 13 ± 1 per patient to 16 ± 1 segments per patient with the contrast. Meanwhile, the Fine study noted regional wall motion abnormalities in three patients (8.3%) and achieved successful myocardial perfusion imaging in 32 patients (88.9%), although some imaging results were affected by movement and/or inadequate heart rate.

“The expanded indication for DEFINITY is a testament to the rigorous research and development efforts undertaken by Lantheus to address unmet medical needs of pediatric patients,” said Jean-Claude Provost, MD, Chief Medical Officer. “We are proud that this approval will extend the benefits of DEFINITY to healthcare professionals who work with these young individuals.”

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