GE Re-Launches Optison Contrast Agent

 

July 12, 2010

The ultrasound contrast agent Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), was reintroducted in the market. It 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.

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. Optison was approved by the U.S. 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.

The American Society of Echocardiography (ASE) recommends the use of contrast whenever two or more left ventricular wall segments are not seen on noncontrast 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 nonenhanced echocardiograms.

With more than 1 million administered doses and nearly 12 years of clinical use, there were only 16 serious adverse events reported. Of these, the most frequently were headache, nausea and/or vomiting, warm sensation or flushing and dizziness.

GE Healthcare Medical Diagnostics: md.gehealthcare.com

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