ICUS Weekly News Monitor 1-13-2017

1.  DOTmed.com HealthCareBusiness,  Jan 12, 2017,  Bracco's LUMASON contrast agent gets FDA approval for use in pediatric ultrasound of the urinary tract for vesicoureteral reflux
 
2.  Yahoo! Finance,  Jan 11, 2017,  The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON®
 
3.  ICUS,  (recorded webinar),  Contrast-enhanced Abdominal Ultrasound; What is it? How does it work? What is it good for?       By  Stephanie R. Wilson, MD
 
4.  ICUS,  (recorded webinar),  Contrast-enhanced Cardiac Ultrasound - A Tutorial       By Steven B. Feinstein, MD
 
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DOTmed.com
HealthCareBusiness
Jan 12, 2017
 
Bracco's LUMASON contrast agent gets FDA approval for use in pediatric ultrasound of the urinary tract for vesicoureteral reflux
 
(PRNewswire) -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound contrast agent to obtain Food and Drug Administration (FDA) approval for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of suspected or known vesicoureteral reflux (VUR) in pediatric patients.
 
VUR is a urinary tract abnormality in neonates, infants and children characterized by retrograde flow of urine from the bladder into the ureter and toward the kidney and represents a common cause of recurrent urinary tract infections and chronic nephropathy in pediatric patients.1 Voiding cystourethrography and direct radionuclide cystography are the imaging procedures currently used to diagnose VUR in the U.S., and both require exposure to ionizing radiation.1
 
"The approval of LUMASON for voiding ultrasonography answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing neonates, infants and young children to the potential harmful effects of ionizing radiation," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "This approval reflects the efforts of Bracco to seek and provide new and expanded indications for this class of products working collaboratively with the FDA."
 
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 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. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.2
 
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting
 
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Yahoo! Finance
Jan 11, 2017
 
The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use,
 
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that the U.S. Food and Drug Administration (FDA) has removed the contraindication for use of LUMASON in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
 
In view of a potential safety hazard deriving from the use of LUMASON in this patient population, i.e., some of the intravenously injected microspheres bypassing the filtering by the lung and entering the arterial circulation, a specific warning has been maintained in the approved labeling of the agent (WARNINGS AND PRECAUTIONS section, 5.3: Systemic Embolization). Also, LUMASON must not be administered by intra-arterial injection.
 
"The removal of this contraindication implies that the FDA has determined that the benefits from the diagnostic information that could be obtained through the use of LUMASON in patients with cardiac shunts may outweigh the risk for systemic embolization," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "FDA review is critical to ensuring the quality, safety and efficacy of contrast agents like LUMASON, and, in general, of medicinal products."
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 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. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.1
 
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting.n patients with cardiac shunts.
 
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Contrast-enhanced Abdominal Ultrasound
What is it? How does it work? What is it good for?
 
Stephanie R. Wilson, MD, FRCPC
Radiologist, Foothills Medical Centre, Calgary
Clinical Professor of Radiology and Medicine, Division of Gastroenterology, University of Calgary
Co-President, International Contrast Ultrasound Society
 
Free ,on-demand lecture presented as part of ICUS Grand Rounds
Recording of a live webinar presented on June 16, 2016
 
image022A certified, pre-recorded one-hour webinar for radiologists, radiologic technologists, gastroenterologists, nephrologists, urologists, oncologists, and internists.
 
Format: ARCHIVED Webinar
Credit:  1.0 AMA-PRA Category 1
Credit:  1.0 ARRT Category A+
Tuition: none
 
 
 
Course Overview
Contrast-enhanced ultrasound (CEUS) imaging requires administration of a microbubble contrast agent and specialized imaging techniques to show sensitive blood flow and tissue perfusion information. CEUS is a safe and easily performed technique that does not require ionizing radiation and has no risk of nephrotoxicity. Although commonly used in Canada, Europe and Asia, the use of microbubble contrast has been off-label and therefore not widely adopted in the U.S.1 The recent Food and Drug Administration approval of a microbubble agent for characterization of focal liver lesions is expected to bring the use of abdominal CEUS into clinical practice in the U.S.
 
This course covers patient indications for abdominal CEUS; how the contrast medium employs gas-filled microbubbles to improve the visualization of abdominal structures; and the benefits and disadvantages of using abdominal CEUS.
 
To register go to:  http://courses.icpme.us/index?string=&keywords=icus&category=&certificate=&format=&author=&x_submission=get
 
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 image015


Contrast-enhanced Cardiac Ultrasound
A Tutorial
 
Steven B. Feinstein, MD, FACC, FESC
Professor of Medicine-Cardiology
Academic Cardiologist, Rush University Medical Center,  Chicago, IL
 
Free, on demand; presented as part of ICUS Grand Rounds


image023A certified one-hour archived webinar for cardiologists, cardiac sonographers, radiologists, and radiologic technologists
 
Format: Archived Webinar
Credit:  1.0 AMA PRA Category 1
Credit:  1.0 ARRT Category A
Tuition: none
 
 
Course Overview
Contrast-enhanced cardiac ultrasound, also called contrast echocardiography, improves the diagnostic applications of non-enhanced echocardiography, including delineation of the left ventricular endocardial borders to better assess ejection fraction and evaluation of blood perfusion and volume.(1) Recent studies have also shown that cardiac echo is also a reliable vehicle for drug delivery for diseases of the cardiovascular system.(2) Contrast echo has a high safety profile compared to contrast enhanced- CT and -MRI and is portable and cost-effective.
 
1. The  Basics. American Society of Echocardiography website. http://contrastzone.com/ Accessed October 17, 2016.
2. Castle J, Feinstein SB. Drug and Gene Delivery using Sonoporation for Cardiovascular Disease. Adv Exp Med Biol. 2016;880:331-338.
 
To register go to:  http://courses.icpme.us/index?string=&keywords=icus&category=&certificate=&format=&author=&x_submission=get

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