Technology | July 12, 2010

GE Relaunches Optison Contrast Agent

July 12, 2010 – GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), 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 and to improve the delineation of the left ventricular endocardial borders. 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 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 non-contrast 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 non-enhanced echocardiograms.

“I am pleased that Optison is back on the market because it offers an important tool for improving the accuracy and reliability of echocardiograms, without unnecessarily exposing patients to ionizing radiation or dye,” said Steven B. Feinstein, M.D., FACC, FESC, professor of medicine and director of echocardiography, Rush University Medical Center, Chicago. “By improving the accuracy of echocardiograms, the use of ultrasound contrast agents also avoids redundant downstream testing."

Optison’s safety profile is supported by more than 1 million administered doses and nearly 12 years of clinical use, with only 16 serious adverse events reported since 1998. Of the reported adverse reactions following the use of Optison the most frequently reported were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness.

Related Content

Guerbet Showcases Ongoing Collaboration With IBM Watson at RSNA 2018
News | Clinical Decision Support | November 21, 2018
Guerbet LLC USA will feature its digital solutions including its ongoing collaboration with IBM Watson Health in...
Voyageur Minerals to Begin Manufacturing Barium Contrast Products With Chief Medical Supply
News | Contrast Media | November 14, 2018
Voyageur Minerals Ltd. signed a joint venture agreement with Chief Medical Supply Ltd (CM) of Calgary, Alberta to...
Osprey Medical and GE Healthcare Launch Acute Kidney Injury Educational Program
News | Angiography | September 25, 2018
September 21, 2018 — Osprey Medical announced a collaboration with GE Healthcare on Osprey’s Be Kind to Kidneys campa
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Scientists Develop New MRI Tool for Cancer Diagnosis and Therapy

Researchers in the laboratory ‘Biomedical Nanomaterials’ of NUST MISIS. Image courtesy of PR Newsfoto/NUST MISIS.

News | Oncology Diagnostics | August 24, 2018
A European research group has developed a system that allows doctors to both improve the accuracy of diagnosing...
Iron Outperforms Gadolinium as MRI Contrast Agent

Scientists at Rice's Laboratory for Nanophotonics added iron chelates (blue) and fluorescent dye (red) to multi-layered gold nanomatryoshkas to create particles that can be used for disease therapy and diagnostics. The "theranostic" nanoparticles have a core of gold (left) that is covered by silica containing the diagnostic iron and dye, which is covered by an outer shell of gold. The particles are about 20 times smaller than a red blood cell, and by varying the thickness of the layers, LANP scientists can tune the nanomatryoshkas to convert light into cancer-killing heat. (Image courtesy of Luke Henderson/Rice University)

News | Contrast Media | August 22, 2018
Rice University nanoscientists have demonstrated a method for loading iron inside nanoparticles to create magnetic...
Guerbet Partners With Imalogix on Dose Optimization With Artificial Intelligence
News | Radiation Dose Management | August 14, 2018
August 14, 2018 — Guerbet LLC USA announced a commercial partnership with Imalogix, a provider of...
Videos | Contrast Media | August 03, 2018
Lawrence Tanenbaum, M.D., FACR, vice president and director of advanced imaging at RadNet, discusses the latest resea
Guerbet, IBM Watson Health Partner on Artificial Intelligence for Liver Imaging
News | Clinical Decision Support | July 10, 2018
Guerbet announced it has signed an exclusive joint development agreement with IBM Watson Health to develop an...
Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...