GE Healthcare of Chalfont St. Giles, U.K., has relaunched its Optison ultrasound contrast agent following a yearlong interruption in supply of the agent.
Optison was originally approved by the U.S. Food and Drug Administration (FDA) in 1998, but GE took it off the market in June 2009 due to what the company called "manufacturing difficulties." The company said that it has conducted a review of the product's manufacturing process and has made changes to minimize any future disruptions in supply.
Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing has not been established, GE said.
The product is one of just two ultrasound contrast agents for cardiology applications commercially available in the U.S., the other being Definity from Lantheus Medical Imaging of North Billerica, MA. Both products were required by the FDA in 2007 to carry black box warning labels due to patient safety concerns. Since 1998, more than 1 million doses of Optison have been administered, with only 16 serious adverse events, GE said.
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