Technology | Contrast Media | October 04, 2016

GE Healthcare Announces FDA Labeling Change for Optison Ultrasound Contrast Agent

Administration has removed contraindication for use in patients with cardiac shunts and for administration by intra-arterial injection

GE Healthcare, Optison ultrasound contrast agent, FDA labeling change, cardiac shunts, intra-arterial injection

October 4, 2016 — GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label change for the ultrasound contrast agent Optison (Perflutren protein-Type A Microspheres Injectable Suspension, USP). The FDA removed the contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection. Both contraindications have been revised and moved to the WARNINGS AND PRECAUTIONS section (5.3 : Systemic Embolization) of the Full Prescribing Information.

Optison is the first contrast agent available in the United States to receive this contraindication label change.

A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal flow of the circulatory system. Previously, in suspected cardiac shunt populations, an agitated saline procedure was needed to determine if a shunt existed and whether the patient was contraindicated to receive an ultrasound contrast agent.

Sharon L. Mulvagh, M.D., professor of medicine, Women's Heart Clinic director, associate director, preventive cardiology consultant in cardiovascular diseases, Mayo Clinic and Mayo Clinic College of Medicine, said: "I am very pleased that the FDA has approved the removal of the cardiac shunt contraindication from the ultrasound contrast agent Optison. This label change will allow more patients access to a diagnostic imaging tool that has established safety and efficacy. The FDA’s decision to remove this contraindication is supported by a body of data from studies demonstrating safety and clinical benefits of all ultrasound contrast agents in patients with cardiovascular diseases.”

She added: “This is an important step forward in eliminating barriers to ultrasound contrast use and delivering quality diagnostic care of value to our patients.”

Steven Feinstein, M.D., co-president of the International Contrast Ultrasound Society, said: “Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they too will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging. The International Contrast Ultrasound Society applauds the FDA for its decision, and believes it will benefit individual patients as well as our healthcare delivery system.”

Jonathan Lindner, M.D., M. Lowell Edwards Professor of Cardiology at the Knight Cardiovascular Center, Oregon Health & Science University, said: “Thanks to the overwhelming weight of evidence from clinical trials, most practitioners in the field of echocardiography already realize the benefits of using contrast agents and understand their capacity to improve diagnostic accuracy, improve outcomes and streamline care. However, a major obstacle to widespread use has been lack of consensus and confusion regarding how far one needs to go to exclude shunts, no matter how small. The decision by the FDA removes a barrier to using this contrast agent, and may result in an increase in the number of labs that will choose to utilize this important technology, which allows clinicians to provide the best care possible.”

For more information: www.gehealthcare.com

Related Content

Franco Fontana, CEO of the Esaote Group, and Xie Yufeng, Chairman of WDM.

Franco Fontana, CEO of the Esaote Group, and Xie Yufeng, Chairman of WDM.

News | Digital Radiography (DR) | July 31, 2020
July 31, 2020 — In the thick of the COVID-19 eme
A and B, Lung ultrasound images obtained with convex (A) and linear (B) probes. Multiple confluent B-lines (arrows), patchy pulmonary consolidation (asterisk, B), and thickened pleural line (between arrowheads, A) are visualized. C, Chest CT image shows reticular and interlobular septal thickening and patchy, focal opacities associated with architectural distortion. This patient was classified in critical group and was assigned to severe group for statistical analysis.

A and B, Lung ultrasound images obtained with convex (A) and linear (B) probes. Multiple confluent B-lines (arrows), patchy pulmonary consolidation (asterisk, B), and thickened pleural line (between arrowheads, A) are visualized. C, Chest CT image shows reticular and interlobular septal thickening and patchy, focal opacities associated with architectural distortion. This patient was classified in critical group and was assigned to severe group for statistical analysis.

News | Coronavirus (COVID-19) | July 23, 2020
July 23, 2020 — 
Hologic, Inc. announced he U.S. launch of the SuperSonic MACH 40 ultrasound system, expanding the company’s suite of ultrasound technologies with its first premium, cart-based system.
News | Breast Imaging | July 08, 2020
July 8, 2020 — Hologic, Inc. announced he U.S.
Fujifilm’s Sonosite SII POC ultrasound system helps to keep crowded areas clearer with a small ultrasound footprint.

Fujifilm’s Sonosite SII POC ultrasound system helps to keep crowded areas clearer with a small ultrasound footprint.

Feature | Ultrasound Imaging | July 07, 2020 | By Joan Toth
With the miniaturization of technology, improved ease of use, lower system cost, increased portability and greater ac
A 3-D ultrasound system provides an effective, noninvasive way to estimate blood flow that retains its accuracy across different equipment, operators and facilities, according to a study published in the journal Radiology.

Volume flow as a function of color flow gain (at a single testing site). For each row the color flow c-plane and the computed volume flow are shown as a function of color flow gain. The c-plane is shown for four representative gain levels, whereas the computed volume flow is shown for 12–17 steps across the available gain settings. Flow was computed with (solid circles on the graphs) and without (hollow circles on the graphs) partial volume correction. Partial volume correction accounts for pixels that are only partially inside the lumen. Therefore, high gain (ie, blooming) does not result in overestimation of flow. Systems 1 and 2 converge to true flow after the lumen is filled with color pixel. System 3 is nearly constant regarding gain and underestimates the flow by approximately 17%. Shown are mean flow estimated from 20 volumes, and the error bars show standard deviation. Image courtesy of the journal Radiology

News | Ultrasound Imaging | July 01, 2020
July 1, 2020 — A 3-D ultrasound