FDA Reviews Ultrasound Contrast Agent for Stress Echocardiography
December 17, 2010 – An ultrasound contrast agent is under review by the U.S. Food and Drug Administration (FDA) for use in stress echocardiography. Lantheus Medical Imaging recently submitted a supplemental new drug application for its Definity (Perflutren Lipid Microsphere) Injectable Suspension.
It is currently indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border. The FDA will now consider whether to broaden its use to include exercise and pharmacologic stress testing.
Echocardiography is widely used for the diagnosis and management of coronary heart disease, congestive heart failure and other cardiopulmonary conditions. Echocardiograms, also called heart ultrasounds, can be performed with and without contrast at rest or combined with either exercise or pharmacologic stress testing.
Numerous patient factors such as body habitus and lung disease can limit the quality of left ventricular images. In the stress echocardiography setting, as much as 30 percent of studies may be technically limited. Contrast agents can be used to improve left ventricular opacification and delineation of the left ventricular endocardial border.
“Contrast echocardiography is well-tolerated, non-invasive, and is a widely available diagnostic tool that provides physicians with critical patient information at the time and point of care and allows physicians to make improved patient management decisions, often helping to avoid other procedures with greater overall risk,” said Mark G. Hibberd, M.D., Ph.D., senior medical director, medical affairs and pharmacovigilance, Lantheus Medical Imaging.
Several studies and trials have shown the safety profiles of contrast echocardiography and noncontrast echocardiography were similar.
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