GE Healthcare Continues Its Commitment to Ultrasound Community

Left Ventricular Opacity Software Now Standard on GE Healthcare’s Vivid E9

GE Healthcare is committed to providing safe, reliable, innovative, and effective diagnostic products that aid in the detection of cardiovascular diseases. That’s why we are so pleased to announce that beginning on Jan 1, 2014, the Vivid E9 XDclear and BT12 consoles will include left ventricular opacity (LVO) Contrast in the standard base configuration.

As a result of this change, customers will no longer need to order the LVO Contrast software option when ordering a Vivid E9 console. The Vivid E9 is GE Healthcare’s leadership cardiovascular ultrasound system designed for cardiac 4D and 2D imaging, with additional capabilities that include pediatric, fetal/obstetrics, peripheral vascular, and transesophageal applications. The inclusion of LVO contrast as standard software is further reflection of GE’s commitment to the ultrasound marketplace.

GE Healthcare further believes that inclusion of LVO contrast as part of the Vivid E9 standard configuration could lead to greater adoption of contrast usage into echocardiographic studies. A recent survey conducted by the American Society of Echocardiography (ASE) found that contrast usage, though gaining, is still low with about half of ASE’s survey respondents employing contrast for 5% or less of studies performed.1 

Ultrasound contrast media brands that are available in the United States include Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP and DEFINITY® Vial for (Perflutren Liquid Microsphere) Injectable Suspension*. They are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventriclular endothelial borders.

WARNING: SERIOUS CARDIOPULMONARY REACTIONS: Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

Please see the Important Risk and Safety Information for Optison below. For similar information about DEFINITY, please see their full prescribing information.

The LVO contrast software on the Vivid E9 enhances delineation of the LV border in combination with ultrasound contrast agents. GE’s Coded Phase Inversion (CPI) provides high-resolution detection of contrast in the LV cavity and excellent suppression of myocardial tissue signals. Tri-plane imaging with the 4V-D Active Matrix 4D Volume Phased Array Probe, in concert with LVO contrast enables acquisition of three simultaneous apical views within one cardiac cycle.

GE Healthcare’s first priority is to assist you in making confident medical decisions for your patients. We are ready to work with you to help ensure that your ultrasound contrast media needs are addressed. To that end, if you are experiencing any delays or issues related to securing your contrast media, please contact us at one of the numbers below.

Additional information about the Vivid E9 is available by contacting GEHC at 888 871 8266, Inquiries about Optison should be directed to 800 292 8514. Healthcare professionals wanting to learn more about Optison can contact Medical Affairs at 800 654 0118 (option 2, then option 3).

*DEFINITY® Vial for (Perflutren Liquid Microsphere) Injectable Suspension is a registered trademark of Lantheus Medical Imaging, Inc. OptisonTM (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is a registered trademark of GE Healthcare.

Important Risk and Safety Information About OptisonTM (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

WARNING: SERIOUS CARDIOPULMONARY REACTIONS: Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

INDICATIONS: Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. CONTRAINDICATIONS: Do not administer Optison to patients with known or suspected: (1) Right-to-left, bi-directional, or transient right-to-left cardiac shunts, or (2) Hypersensitivity to perflutren, blood, blood products, or albumin. Do not administer Optison by intra-arterial injection. WARNINGS: Anaphylactoid Reactions: In postmarketing use, uncommon but serious anaphylactoid reactions were observed during or shortly following perflutren-containing microsphere administration, including in patients with no prior exposure to perflutren-containing microsphere products. High Ultrasound Mechanical Index: High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The safety of Optison at mechanical indices greater than 0.8 and the safety of Optison with the use of end-systolic triggering have not been evaluated. PRECAUTIONS: General: Optison contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease and Creutzfeldt-Jakob disease (CJD), no cases of which have ever been identified for albumin. Pregnancy: Adequate or well-controlled studies were not conducted in pregnant women. Optison should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Optison is administered to a nursing woman. Pediatric Use: Safety and efficacy have not been established in pediatric patients, or in patients with congenital heart disease. ADVERSE REACTIONS: The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Postmarketing Experience: Cardiac arrests, and other serious, but non-fatal adverse reactions, were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress, or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions.

Please see the Full Prescribing Information for Optison.

1 American Society of Echocardiography Contrast Usage Survey Results, October 2013.

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