GE Healthcare Medical Diagnostics has reintroduced the 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.
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.
GE Healthcare said that the recommended dose is 0.5ml injected into a peripheral vein. This may be repeated for further contrast enhancement as needed, but the maximum total dose should not exceed 8.7ml in any one patient study.
Reportedly, 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 minimise any future disruptions to product supply.
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.
Kimberly Wolf, regional marketing leader-Americas at GE Healthcare Medical Diagnostics, said: “We are excited to announce the reintroduction of Optison. 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.”