Lantheus Announces the FDA Approval of DEFINITY (Perflutren Lipid Microsphere) for Pediatric Patients - Seite 2

The Golding study, together with supportive data from the Fine and Kutty studies, demonstrate that left ventricular opacification with DEFINITY (cumulative doses ranging from 6 µL/kg to 20 µL/kg) is successful in pediatric patients and that ultrasound contrast provides important information to guide management in such patients. In the Golding study, both the ability to detect wall motion abnormalities and the ability to perform ejection fraction determinations were improved in the majority (70% and 80%, respectively) of subjects. The Kutty and Fine studies each reported successful left ventricular opacification in all participants. In the Kutty study, wall motion and/or myocardial perfusion wall motion abnormalities were identified in 13 (11.5%) of the patients (all identified during stress testing), and the number of left ventricular segments visualized improved from 13 ± 1 per patient without contrast to 16 ± 1 segments per patient with contrast across all patients. The Fine study identified regional wall motion abnormalities detected in three patients (8.3%, n=36), and demonstrated successful myocardial perfusion imaging in 32 patients (88.9%), with imaging in some patients complicated by movement and/or insufficient heart rate factors.^4-6     

All reported adverse events across all trials were mild, brief and reversible without intervention. Specifically, the Golding study reported no AEs among study participants; the Fine study reported that 33% of patients experienced mild AEs (palpitations, headache, nausea and shortness of breath) attributed to stress test procedures and not as a result of DEFINITY administration; and the Kutty study reported 11% of patients experienced AEs with no differences between DEFINITY and those patients who did not receive DEFINITY in frequencies of adverse events (chest/back/neck pain, headache, fatigue, dizziness, shortness of breath).^4-6  

About DEFINITY 
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound enhancing agent approved for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).⁶ DEFINITY is the most utilized, extensively studied and a trusted ultrasound enhancing agent with more than 20 years in the market.^1-3