PRINCETON, N.J., July 12 /PRNewswire/ -- GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. 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. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.
"We are excited to announce the reintroduction of Optison," said Kimberly Wolf, Regional Marketing Leader - Americas, GE Healthcare Medical Diagnostics. "The product gives medical professionals an option in ultrasound contrast agent when they need to increase diagnostic accuracy by converting non-diagnostic echo studies to diagnostic images."
Optison is an FDA-approved ultrasound contrast agent available in a ready-to-use formulation, providing the benefits of fast preparation time, ease of use, portability, and flexible dosing. The recommended dose is 0.5 mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed, but the maximum total dose should not exceed 8.7 mL in any one patient study.
Optison was approved by the US Food and Drug Administration (FDA) in 1998. In June 2009, GE Healthcare was no longer able to supply Optison to the market due to manufacturing difficulties. Since that time, the company has conducted a thorough review of the manufacturing process and changes have been made to minimize any future disruptions to product supply.
"Optison gives cardiologists, sonography professionals, cardiac catheterization laboratory nurses, echocardiography laboratory staff, and most importantly patients, an additional option in ultrasound contrast agent selection," said Anthony N. DeMaria, MD, Professor of Medicine, Judith and Jack White Chair in Cardiology at the University of California, San Diego School of Medicine.
According to the Intersocietal Commission for the Accreditation of Echocardiography Laboratories (ICAEL), an estimated 10 million echocardiograms are performed in the United States each year. As many as 30% of patients receiving stress echocardiography may receive nondiagnostic or poor-quality images. Echocardiographic contrast agents can improve imaging. Clinical trials demonstrate that suboptimal echocardiograms can be converted to diagnostic examinations in 75% to 90% of patients.
The American Society of Echocardiography (ASE) recommends the use of contrast whenever two or more left ventricular wall segments are not seen on non-contrast images. In clinical studies supporting the marketing application of Optison, there was significantly increased left ventricular heart opacification and improved endocardial border delineation with Optison compared to non-enhanced echocardiograms.
"I am pleased that Optison is back on the market because it offers an important tool for improving the accuracy and reliability of echocardiograms, without unnecessarily exposing patients to ionizing radiation or dye," said Steven B. Feinstein, MD, FACC, FESC, Professor of Medicine and Director of Echocardiography, Rush University Medical Center, Chicago. "By improving the accuracy of echocardiograms, the use of ultrasound contrast agents also avoids redundant downstream testing."
Optison's safety profile is supported by more than 1 million administered doses and nearly 12 years of clinical use, with only 16 serious adverse events reported since 1998. Of the reported adverse reactions following the use of Optison the most frequently reported were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Some adverse reactions have been identified during the postmarketing use of perflutren-containing microsphere products. Fatal 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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Important Risk and Safety Information About Optison
Important Boxed Warning and Risk Information About Optison
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 Optison 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 Optison administration (see WARNINGS).
- Always have resuscitation equipment and trained personnel readily available
Please see continued Important Risk and Safety Information in Full Prescribing Information at http://www.gehealthcare.com/usen/docs/optison%20PI.pdf
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. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.
Do not administer Optison to patients with known or suspected:
Right-to-left, bidirectional, or transient right-to-left cardiac shunts,
Hypersensitivity to perflutren, blood, blood products, or albumin (see WARNINGS).
Do not administer Optison by intra-arterial injection.
Safety and efficacy have not been established in pediatric patients, or in patients with congenital heart disease (see WARNINGS).
In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included fatal cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or fibrillation), hypotension, respiratory distress, or cardiac ischemia (see ADVERSE REACTIONS).
Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Optison administration and monitor all patients for acute reactions.
Postmarketing reports of acute anaphylactoid reactions including shock, bronchospasm, upper airway swelling, loss of consciousness, urticaria, and pruritus, have occurred in patients with no prior exposure to perflutren-containing microsphere products. Monitor all patients for signs and symptoms of anaphylactoid reactions (see ADVERSE REACTIONS).
This product 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.
A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral disease or CJD have ever been identified for albumin.
The following adverse reactions have been identified during the postmarketing use of perflutren-containing microsphere products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Fatal cardiac arrests and other serious but nonfatal 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 (see WARNINGS).
Prior to Optison administration, please read the Full Prescribing Information, which is available here: http://www.gehealthcare.com/usen/docs/optison PI.pdf
SOURCE GE Healthcare Medical Diagnostics