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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![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
