The Contrast is Clear
*Pooled data on file from 126 patients in two open-label multicenter trials with similar study design and patient populations. Results from institutional reads refer to percentage of patients with improvement in segmental endocardial border delineation after administration of one or more 10 uL/Kg boluses of DEFINITY®. Tests of significance were conducted using 2-sided McNemar’s test at the 5% level of significance.
- Source: The Echocardiography Monthly Monitor: United States, October 2001-September 2008, Arlington Medical Resources, Inc., Malvern, PA ©2008 Arlington Medical Resources, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.
- Mulvagh SL et al. contrast Echocardiography: Current and future applications. J Am Soc Echocardiogr 2000; 13:331-42.
- Kitzman DW et al. Efficacy and Safety of the Novel Ultrasound Contrast Agent Perflutren (Definity) in Patients With Suboptimal Baseline Left Ventricular Echocardiographic Images. Am J Cardiol. 2000; 86:669-674.
- Data on File, Lantheus Medical Imaging, Inc.
- DEFINITY® US Package Insert.
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June 14, 2010 - Lantheus Medical Imaging, Inc. Presents at American Society of Echocardiography Annual Meeting
Press Release
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Using contrast may help answer the clinical questions in suboptimal echoes 2,3 Learn More
DEFINITY® significantly improves endocardial border delineation- the greatest improvements occur in the lateral and anterior walls.3,4* See the Results
Only Contrast Agent FDA-Approved for Bolus IV and Continuous IV Administration. Learn more
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INDICATIONS
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established.
CONTRAINDICATIONS
Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS).
- In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS).
- Always have resuscitation equipment and trained personnel readily available.
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In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please See Full Prescribing Information and Letter to Healthcare Providers.
