• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

FDA Approves Pediatric Use of Ultrasound-Enhancing Agent in Suboptimal Echocardiogram Cases

News
Article

A recent pediatric clinical trial revealed that left ventricular opacification with the ultrasound agent Definity improved ejection fraction assessment for 80 percent of patients.

The Food and Drug Administration (FDA) has granted approval for the use of the ultrasound contrast agent Definity (perflutren lipid microsphere) in pediatric patients with suboptimal echocardiograms.

Through opacification of the left ventricular chamber on ultrasound, Definity facilitates improved visualization of the left ventricular endocardial border, according to Lantheus, the manufacturer of Definity.

Lantheus noted the FDA approval was based on findings from three pediatric clinical trials. One study demonstrated enhanced detection of wall motion abnormalities in 70 percent of patients and improved determination of ejection fraction in 80 percent of patients.

"While (Definity) has long demonstrated its effectiveness in providing better outcomes in adults over the past two decades, this new FDA decision offers a critical diagnostic tool for pediatric heart patients and their families,” said Kassa Darge, M.D., Ph.D, radiologist-in-chief and chair of the Department of Radiology at Children’s Hospital of Philadelphia. “This approval will offer a valuable alternative to pediatric cardiologists trying to do imaging work up in challenging pediatric cardiac cases.”

Related Videos
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Nina Kottler, MD, MS
Radiology Challenges with Breast Cancer Screening in Women with Breast Implants
Related Content
© 2024 MJH Life Sciences

All rights reserved.