Frequently Asked Questions
What is DEFINITY®?
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension is Lantheus Medical Imaging Inc.’s non-blood based ultrasound contrast agent approved by the United States Food and Drug Administration (FDA). DEFINITY® is the first approved ultrasound contrast agent in the U.S. that offers flexible dosing and administration through IV bolus injection or continuous IV infusion.1
What is DEFINITY® approved for?
The FDA has approved activated DEFINITY® 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 in stress has not been studied1.
What are the contraindications for DEFINITY®?
Do not administer DEFINITY® to patients with known or suspected:
Right-to-left, bi-directional, or transient right-to-left cardiac shunts,
Hypersensitivity to perflutren
Do not administer DEFINITY® by intra-arterial injection.1
What is DEFINITY® made of?
DEFINITY® is comprised of lipid-coated microspheres filled with octafluoropropane gas. DEFNITY® does not contain any human or animal materials. The microspheres contained in DEFINITY® have a mean diameter of 1.1 to 3.3 microns (in vitro measurements)1 The microspheres are stable and small enough to pass through the pulmonary capillaries.2,3
How does DEFINITY® work?
After activation of DEFINITY® and intravenous injection, the physical acoustic properties of activated DEFINITY® provide contrast enhancement of the endocardial borders during echocardiography. The perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood.1
Why are ultrasound contrast agents such as DEFINITY® helpful?
Up to 20% of resting echo studies result in suboptimal echocardiograms.4,5,6
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.4,5 Activated DEFINITY® 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.
Imaging agents are particularly useful when examining technically difficult patients who often have suboptimal images.7,8,9 Some populations such as patients with obesity, with lung disease, undergoing mechanical ventilation and in critical care areas. It should be noted that DEFINITY® has not been used in specific clinical trials on these patient types.
Imaging agents may enhance efficiency by reducing downstream resource use.5,7,8,9
Where would a study with activated DEFINITY® be performed?
An exam using activated DEFINITY® may be performed at any location that uses diagnostic ultrasound equipment and has patients with suboptimal images. For example, a private physician’s office, hospital imaging facility or clinic. Ultrasound is widely available and can be found in most healthcare settings.
Are there any side effects to an ultrasound exam using activated DEFINITY®?
The safety of DEFINITY® is well documented in multiple clinical trials involving over 1,700 patients at more than 20 U.S. medical centers. Age, gender, race and ethnicity did not affect the overall incidence of adverse events. For more information, please refere to the Safety page of this website.1
Are ultrasound contrast agents reimbursed by private insurance or Medicare?
Coverage for contrast agents in many cases is available- but reimbursement policies vary from insurer to insurer, and you will need to check in each case. Lantheus Medical Imaging, Inc. provides basic reimbursement information on DEFINITY® for healthcare professionals through the DEFINITY® Reimbursement Support Line: 1-800-362-2668 x7995. However, Lantheus Medical Imaging, Inc. cannot guarantee that use of any information provided will result in coverage or payment at any particular level.
Full Prescribing Information including boxed WARNING on Serious Cardiopulmonary Reactions and other information about DEFINITY® is available on this site and by calling 1-800-343-7851. For assistance with product-related reimbursement questions regarding DEFINITY® please call 1-800-362-2668 x7995.
- DEFINITY® Prescribing Information
- McCulloch M et al Ultrasound contrast physics: A series on contrast echocardiography., article 3. J Am Soc Echocardiogr 2000: 13: 959-67.
- Lindner JR et al. Microvascular rheology of Definity microbubbles after intra-arterial and intravenous administration J Am Soc Echocardiogr 2002; 15(5): 396-403.
- Waggoner AD, et al, Guidelines for the cardiac sonographer in the performance of contrast echocardiography. J Am Soc Echocardiogr. 2001: 417-420.
- Mulvagh SL et al. contrast Echocardiography: Current and future applications. J Am Soc Echocardiogr 2000; 13:331-42.
- Edited by Scott d. Solomon, MD, Essential Echocardiography, A Practical handbook with DVD. Humana Press; 2007 Chapter 5: Ventricular Systolic function, P113.
- Shaw Lj et al. Clinical and economic outcomes assessment with myocardial contrast echocardiography. Heart; 1999:82: 16-21.
- Castello R et al. Efficacy and time-efficiency of a “sonographer driven” contrast echocardiography protocol in a high-volume echocardiography laboratory, Am heart J 2003; 145 535-541.
- Burgess P et al Performing an Echocardiographic Examination with a Contrast Agent: A Series on Contrast Echocardiography Article 2. JASE 2000: 13 629-636.