Cardiology A '2nd-generation' ultrasound contrast medium consisting of a solution of gas-filled microbubbles with a mean bubble size 4 µm, range 1–10 µm produced by sonicating a 5% albumin solution. See Sonicated albumin. Cf Albunex®.
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Food and Drug Administration (FDA) to allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) in-house.
Although Optison is currently the only FDA approved polymer shelled CA and some such as Sonovist (Schering, Berlin) with a cyanoacrylate shell, have been withdrawn due to adverse side effects, the role of CA within the U.
Two ultrasound contrast agents, Definity (Bristol-Meyers Squibb) and Optison (GE Healthcare), are approved in the United States for use to improve suboptimal echocardiograms.
Optison is a contrast agent that may improve the visualization of the left ventricular border - an area of the heart that is critical to see in order to assess and diagnose certain heart diseases.
For example, after passage through the heart, Albunex lasts for only 15-30 seconds, and Optison for about 2 minutes.
However, recent shortages in DEFINITY have left an opening for GE Healthcare's slightly lower-cost Optison to gain share.
However, two other ultrasound contrast agents -- Optison (GE Healthcare) and Definity (Lantheus Medical Imaging) -- are FDA-approved for cardiac imaging in the United States.
Revised label for contrast agent Optison modifies patient monitoring and observation requirements
We are excited to announce the reintroduction of Optison," said Kimberly Wolf, Regional Marketing Leader - Americas, GE Healthcare Medical Diagnostics.
Optison Also Gained Market Share During the Same Study Period, According To New Data from Arlington Medical Resources
WASHINGTON -- An international medical specialty society today announced support for a proposed FDA label change that would affect the use of Optison, an ultrasound contrast agent marketed by GE Healthcare for use in improving the accuracy and reliability of radiation-free imaging procedures known as "contrast-enhanced ultrasound" (CEUS).