FDA approves cardiac ultrasound enhancing agent for pediatric patients
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Key takeaways:
- The FDA approved perflutren lipid microsphere injection to improve ultrasound imaging in pediatric patients.
- The agent may improve left ventricular opacification in patients with suboptimal echocardiograms.
Lantheus Holdings announced the FDA has approved the supplemental new drug application for its perflutren lipid microsphere injection to improve ultrasound imaging in pediatric patients with suboptimal echocardiograms.
The approval was based on positive data from three pediatric clinical trials that evaluated the use of the perflutren lipid microsphere injection (Definity) in a total of 189 patients (57% boys), according to a press release from the company.
The three studies demonstrated successful left ventricular opacification with cumulative doses ranging from 6 µL/kg to 20 µL/kg.
In addition, detection of wall motion abnormalities, the ability to perform ejection fraction determinations and the number of LV segments visualized were improved, according to the release.
All adverse events were mild, brief and reversible without intervention and included palpitations, headache, nausea and shortness of breath.
"While DEFINITY has long demonstrated its effectiveness in providing better outcomes in adults over the past 2 decades, this new FDA decision offers a critical diagnostic tool for pediatric heart patients and their families,” Kassa Darge, MD, PhD, radiologist-in-chief and chair of the department of radiology at Children’s Hospital of Philadelphia, said in the release. “This approval will offer a valuable alternative to pediatric cardiologists trying to do imaging workup in challenging pediatric cardiac cases.”
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