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

Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
Videos | Magnetic Resonance Imaging (MRI) | December 19, 2017
Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pitt
The FDA issued new warnings on MRI gadolinium contrast agents. (GBCAs)

The FDA issued new warnings on MRI gadolinium contrast agents. 

Feature | Magnetic Resonance Imaging (MRI) | December 19, 2017
The U.S.
Brainlab Contrast Clearance Analysis Software Receives FDA 510(k) Clearance
Technology | Contrast Media | December 12, 2017
Brainlab announced U.S. Food and Drug Administration (FDA) clearance of its Contrast Clearance Analysis methodology,...
Sectra Offers Gadolinium Tracking Functionality in DoseTrack Software
Technology | Contrast Media | December 11, 2017
December 11, 2017 — Sectra recently announced the global introduction of gadolinium tracking in its dose monitoring s
Videos | Magnetic Resonance Imaging (MRI) | December 07, 2017
Max Wintermark, M.D., professor of radiology and chief of neuroradiology, Stanford Hospital and Clinics, discussed MR
Guerbet to Participate in French Interventional Radiology Conference
News | Contrast Media | October 10, 2017
Guerbet announced it will be taking part in the 65th edition of the Journées Francophones de Radiologie (JFR) that will...
Trends in contrast media used in magnetic resonance imaging and computed tomography

Image courtesy of Bayer

Feature | Contrast Media | October 04, 2017 | By Dave Fornell
Over the past decade, several clinical studies have shown gadolinium-based magnetic resonance imaging (MRI) contrast...
FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents
News | Contrast Media | September 12, 2017
The U.S. Food and Drug Administration’s (FDA) Medical Imaging Drugs Advisory Committee (MIDAC) voted overwhelmingly...
Overlay Init