- Category: ICUS Weekly News Monitors
1. Healio, Apr 5, 2016, FDA approves Lumason for hepatic lesions in adults, children
2. DOTmed.com, April 04, 2016, FDA clears LUMASON, Bracco contrast agent, for liver ultrasound By Gus Iversen
3. AuntMinnie.com, Mar 30, 2016, Ultrasound Insider By Erik Ridley
Apr 5, 2016
FDA approves Lumason for hepatic lesions in adults, children
The FDA has approved Lumason for use in ultrasonography of the liver to differentiate between hepatic lesions in adult and pediatric patients, according to a press release from the manufacturer.
Lumason (sulfur hexafluoride lipid-type A microspheres, Bracco Diagnostics), a contrast agent comprised of gas-filled microspheres that reflect sound waves to enhance an image, will improve the sensitivity and specificity of ultrasonography to better differentiate between malignant and benign focal hepatic lesions. It is the first approved ultrasound contrast agent for children, according to the release.
“Bracco is delighted to obtain FDA approval for the use of Lumason in liver imaging for both adult and pediatric patients,” Fulvio Renoldi Bracco, head of global business unit imaging at
Bracco Imaging, said in the release. “The use of contrast-enhanced ultrasound for characterization of focal liver lesions is already established in several countries in Europe and Asia, and Bracco is glad to offer this diagnostic option to U.S. patients.”
The FDA first approved Lumason in 2014 for use in echocardiograms of patients whose ultrasound image of the heart were too difficult to see with ultrasound waves.
Lumason should only be used for ultrasonography of the liver for liver lesions and in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms, according to the release.
Contraindications for use mentioned in the release include: known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, and history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients.
April 04, 2016
FDA clears LUMASON, Bracco contrast agent, for liver ultrasound
by Gus Iversen , DOTmed News Online Editor
Bracco announced today that the FDA has given clearance to the contrast agent LUMASON for use in liver ultrasound for characterization of focal liver lesions. The agent — known globally as SonoVue — is also now the first ultrasound contrast agent approved in the U.S. for use in pediatric patients.
"The use of contrast-enhanced ultrasound for characterization of focal liver lesions is already established in several countries in Europe and Asia, and Bracco is glad to offer this diagnostic option to U.S. patients," said Fulvio Renoldi Bracco, Head of Global Business Unit Imaging at Bracco Imaging, in a statement.
LUMASON had already been cleared by the FDA for use in adults with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients. That approval took place in October 2014.
The agent has been marketed for over 14 years in more than 40 countries. It is made up of gas-filled microspheres that reflect sound waves to enhance ultrasound images.
"The expanded indication for LUMASON now offers health care professionals and their patients further benefits of our ultrasound contrast agent," said Vittorio Puppo, CEO and president of Bracco Diagnostics, in the release. "This approval demonstrates Bracco's leadership and commitment to the imaging community, across imaging modality and service lines. We are proud to be a leader in contrast imaging and delivery systems, and of our continuous investment in imaging activities to help improve patient care in the U.S."
Mar 30, 2016
By Erik Ridley
Contrast-enhanced ultrasound (CEUS) is employed routinely -- and to substantial clinical benefit -- around the world for radiology applications. However, in the U.S., regulatory clearance has remained limited to cardiology indications.
The seemingly interminable delay has long stuck in the craw of ultrasound contrast experts, many of whom now advocate that this valuable problem-solving tool be used off-label in the U.S. There's never been a better time: CEUS seems well-positioned to benefit from growing questions over radiation exposure and the risk of contrast-induced nephrotoxicity from contrast-enhanced CT, as well as concerns about the safety of gadolinium-based MR contrast agents.
In a presentation at the American Institute of Ultrasound in Medicine (AIUM) annual meeting in New York City, Dr. Michelle Robbin from the University of Alabama at Birmingham shared some tips for integrating CEUS into your practice now. Our coverage of her presentation is this newsletter's Insider Exclusive, which you have access to before our regular members.
Speaking of CEUS, another presentation at AIUM 2016 reported that the combination of contrast-enhanced transrectal ultrasound-guided biopsy and medially directed sextant biopsy was the best biopsy approach for the vital task of detecting high-grade prostate cancers.
Also at AIUM 2016, researchers shared how a focused cardiac ultrasound exam yielded a faster and more accurate diagnosis for thoracic aortic dissection, also known as the "Great Masquerader."
Meanwhile, Dr. Stamatia Destounis of Elizabeth Wende Breast Care in Rochester, NY, reported that ultrasound screening in women with dense breasts can identify invasive cancers not seen on mammography, and that performance improves with experience. What else did the outpatient breast center learn during its second year of providing breast ultrasound screening for women with dense breasts?
If widely adopted, prenatal ultrasound could significantly affect half of maternal deaths in the developing world, according to Dr. Alfred Abuhamad of Eastern Virginia Medical School. Click here for our coverage of the plenary session at AIUM 2016.
In big industry news this month, Canon completed a $5.9 billion acquisition of Toshiba Medical Systems. Click here to get all of the details in our report by Editor-in-Chief Brian Casey.
Also, a quantitative ultrasound computer-aided detection algorithm is showing promise for diagnosing several diseases at once. International Editor Eric Barnes has our coverage.
Finally, Italian researchers found that CEUS is useful for characterizing small renal masses that are indeterminate on contrast-enhanced CT or MRI.