Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients
This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.
- This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.
- Currently, DEFINITY is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.1-3
“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.”
Clinical studies have substantiated the efficacy and safety of DEFINITY in pediatric patients. - The Kutty and Fine studies each reported successful left ventricular opacification in all participants.