The New UEA Study Reveals Low AE Incidence for LUMASON!
By MedTech Outlook | Thursday, August 01, 2019
The studies show a low incidence of adverse events when ultrasound enhancing agents are used for transthoracic echocardiography.
FREMONT, CA: The medical imaging organization Bracco Diagnostics, a subsidiary of Bracco Imaging recently revealed the results of a new prospective clinical study covering the use of ultrasound enhancing agents (UEAs) in transthoracic echocardiography. The study bolsters the proven safety profile of its LUMASON ultrasound enhancing agent (UAE). Not only was the incidence of adverse events (AEs) in the study extremely low, but the observed AEs were non-serious.
UEAs are leveraged in echocardiography to enhance image quality, which is often hindered by patient conditions such as large body habitus, increased anterior-posterior diameter, and excessive cardiac motion. UAEs facilitate the real-time evaluation of intracardiac blood flow in patients.
The advantages of UAEs are indisputable, as they have significantly improved the quality and cost-effectiveness of cardiac and clinical care. However, the agents are often underutilized in the clinical landscape due to concerns regarding allergic reactions. The new study shows a very low incidence of AEs with regular clinical use of UAEs and endorses their use on all appropriate patients, including the ones with intracardiac shunts.
Bracco Imaging is an established name in the diagnostic imaging business, offering products and solutions designed for critical diagnostic imaging modalities, including X-ray imaging, magnetic resonance imaging (MRI), contrast-enhanced ultrasound (CEUS), and nuclear medicine through radioactive tracers. The robust diagnostic imaging portfolio is complemented by a wide range of medical devices and advanced administration systems for contrast imaging products.
The prospective observational study was performed at Oregon Health & Science University to determine the rate and severity of AEs after UEA administration, assess the effect of microbubbles in patients with intracardiac shunts, and evaluate the difference in AEs among LUMASON, Definity, and Optison, the UEAs approved by the US Food and Drug Administration (FDA).
The studies revealed 14 AEs, which amounts to 0.25 percent. Also, the observed AEs were non-serious. The patients having intracardiac shunts showed no AE incidence. The AE rate was considerably more for Definity, which showed 13 AEs, and considerably less for LUMASON, which resulted in 1 AE.
The study has stirred considerable interest in the clinical communities in Europe and the US, which are seeking reliable information regarding the safety of medicines in real-world clinical settings. The post-approval studies also show positive results, demonstrating the low-risk of UAEs in diagnostic imaging.