GE's Optison re-enters U.S. market

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GE Healthcare Medical Diagnostics has reintroduced Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), 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, according to the company. 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 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, according to the company.

The FDA approved Optison in 1998. However, in June 2009, GE said it was no longer able to supply Optison in the U.S. “due to manufacturing difficulties.” Since that time, the company said it has conducted a review of the manufacturing process and changes have been made to minimize any future disruptions to product supply.

Incidentally, in July 2008, the European Commission had suspended the marketing authorization of GE’s Optison, a diagnostic contrast agent used in echocardiograms, and the contrast agent has yet to re-enter the European market.