CHICAGO--(BUSINESS WIRE)--The International Contrast Ultrasound Society (ICUS), an international physician group, today commended the U.S. Food and Drug Administration (FDA) on its historic decision to allow the use of Lumason®, an ultrasound contrast agent, for diagnostic imaging of the liver in adults and children. Lumason®, which is sold by Bracco Diagnostics, is the first ultrasound contrast agent to be approved by the FDA for non-cardiac imaging in the US.
ICUS has long advocated for broader acceptance and appropriate use of ultrasound contrast agents, which have strong safety profiles and reduce overall health care costs without exposing patients to ionizing radiation.
Overseas, the use of ultrasound contrast agents is well established for imaging organ systems throughout the body. However, until now their use in the US has been restricted to cardiac imaging only.
"The American radiology community has long awaited an approved ultrasound contrast agent for non-cardiac imaging," according to Dr. Edward Grant, an ICUS board member and Chairman of the Department of Radiology at USC Keck School of Medicine. He said the FDA decision is "a huge step forward" that finally brings state-of-the-art non-invasive ultrasound imaging to patients in the US.
In addition to Lumason®, two other ultrasound contrast agents are FDA-approved in the US for cardiac imaging: Definity® (Lantheus Medical Imaging) and Optison® (GE Healthcare). Outside the US, Lumason® is marketed as SonoVue® and is widely used to for imaging the liver, heart and other organ systems.
All three ultrasound contrast agents are injected into a patient's arm vein during an ultrasound scan. They are made up of suspensions of gas-filled microspheres that reflect sound waves to enhance the clarity of ultrasound images.
"Ultrasound contrast agents are safe, low cost, and completely radiation-free imaging tools that can improve the clarity and reliability of front-line ultrasound scans, avoid unnecessary downstream testing, save lives and lower overall health care costs," according to Dr. Steven Feinstein, Co-President of ICUS, who is an expert in cardiac contrast-enhanced ultrasound (CEUS) and professor of medicine at Rush University Medical Center in Chicago.
"This decision will spare many patients, including children, from the cumulative effects of ionizing radiation that are inherent in certain alternative diagnostic imaging options, including SPECT and CT,” according to Dr. Stephanie Wilson, Co-President of ICUS and an expert in radiological CEUS. She is a Clinical Professor of Radiology and Gastroenterology at the University of Calgary.
The approval also makes Lumason® the first ultrasound contrast agent approved for use in the pediatric population, and will be an especially welcome option for children's medical care. "Children are significantly more sensitive to ionizing radiation than adults," according to Dr. Kassa Darge, an ICUS board member and expert in pediatric CEUS. Dr. Darge is Chief of the Division of Body Imaging, Department of Radiology at The Children's Hospital of Philadelphia.
Darge was the lead author of a white paper submitted to the FDA in 2013 by ICUS and the Society of Pediatric Radiology. The paper concluded that there was a "pressing need" to explore effective radiation-free imaging alternatives in pediatric medicine, and that the use of ultrasound contrast agents in children was "widely accepted throughout Europe and parts of the world other than the United States."
The ICUS Board and imaging professionals had long awaited this significant FDA action that brings the US into line with the rest of the world and gives patients access to the some of the same non-invasive, non-radiation-based diagnostic imaging that has been available around the world for decades.
ICUS is an international, multi-disciplinary, not-for-profit medical society that is exclusively dedicated to advancing the use of contrast enhanced ultrasound diagnostic imaging to improve patient care worldwide. Founded in September 2008, ICUS brings together physicians, scientists, and other ultrasound imaging professionals from over 55 countries. ICUS members represent diverse specialties such as cardiology, radiology, vascular imaging, gastro-intestinal imaging, oncology, OB-GYN, and hepatology. For more information about ICUS, please visit www.icus-society.org.