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Why Use DEFINITY®? PROVEN EFFICACY PROFILE

DEFINITY® improves visualization in the vast majority of studies—with the greatest improvement in lateral and anterior walls.1,2*

Using contrast may help answer the clinical question in suboptimal echoes2,3

Up to 20% of resting studies will result in suboptimal echocardiograms3,4,5

The use of contrast may reduce the need for subsequent testing2,6

A suboptimal image is one in which at least 2 out of 6 myocardial segments of the left ventricle cannot be visualized in the apical views, as defined by the American Society of Echocardiography (ASE) 3,4

*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 10µL/Kg boluses of DEFINITY®. Tests of significance were conducted using 2-sided McNemar's test at the 5% level of significance.

  1. Data on File, Lantheus Medical Imaging, Inc
  2. 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.
  3. Mulvagh SL et al. contrast Echocardiography: Current and future applications. J Am Soc Echocardiogr 2000; 13:331-42.
  4. Waggoner AD, et al, Guidelines for the cardiac sonographer in the performance of contrast echocardiography. J Am Soc Echocardiogr. 2001: 417-420.
  5. Edited by Scott d. Solomon, MD, Essential Echocardiography, A Practical handbook with DVD. Humana Press; 2007 Chapter 5: Ventricular Systolic function, P113.
  6. Shaw LJ et al. Clinical and economic outcomes assessment with myocardial contrast echocardiography. Heart 1999; 82(Suppl III): III16-III21.
  7. Lang RM et al. Recommendations for chamber quantification: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr 2005; 18(12): 1440-1463.

Apical 4-Chamber: Percentage improvement in
evaluability by segment 1*

Apical 4-Chamber 7


Apical 2-Chamber: Percentage improvement in
evaluability by segment 1*

Apical 2-Chamber7


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.


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.