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GE Healthcare Medical Diagnostics Re-launches Optison™ Contrast Agent
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GE Healthcare Medical Diagnostics 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, 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 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, 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.
