ICUS Weekly News Monitor 2-9-2017

1.  Mass Device,  Feb 2, 2017,  Lantheus wins FDA nod for Definity imaging agent label update     By Fink Densford
 
2.  StreetInsider.com,  Feb 2, 2017,  Lantheus (LNTH) Announces FDA Approval of DEFINITY Label Update
 
3.  RSNA Radiology,  Feb 1, 2017,  Integration of Contrast-enhanced US into a Multimodality Approach to Imaging of Nodules in a Cirrhotic Liver: How I Do It     Authors: Patricia C. Jo, MD, et al
 
 
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Mass Device
Feb 2, 2017
Lantheus wins FDA nod for Definity imaging agent label update
By Fink Densford
 
Lantheus Medical Imaging (NSDQ:LNTH) said today it won FDA approval for a label update on its Definity imaging agent which removed a contraindication related to use in patients with a known or suspected cardiac shunt.
 
The agent is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border, the North Billerica, Mass.-based company said.
 
The FDA’s decision to remove the contraindication was based on publications and data supporting the safety of the contrast fluid in patients with cardiac shunts, Lantheus said.
 
“The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for Definity in patients with cardiac shunts. This is particularly noteworthy as Definity is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older. This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes,” Dr. Neil Weissman of Washington D.C.’s MedStar Health Research Institute
 
“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of Definity, which has been used to perform more than seven million echocardiography studies. The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to Definity when undergoing cardiac ultrasound imaging,” chief medical officer Cesare Orlandi said in a press release.
 
Last September, Lantheus priced a $40 million offering with funds slated to pay down approximately $55 million of the outstanding principal balance under its senior secured credit facilities.
 
In August, Lantheus sold its Australian radiopharmacy servicing business to Global Medical Solutions.
 
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StreetInsider.com
Feb 2, 2017
 
Lantheus (LNTH) Announces FDA Approval of DEFINITY Label Update
 
Lantheus Medical Imaging, Inc. (“Lantheus”) today announced U.S. Food and Drug Administration (FDA) approval of an important label update for DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension which removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the U.S. Prescribing Information. DEFINITY is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
 
A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal path of the circulatory system, which may present in 10 to 35 percent of patients. These patients were previously excluded from receiving a valuable echo contrast study of the left ventricle. The FDA’s decision to remove the contraindication concerning known or suspected cardiac shunts was based on Lantheus’ submission referencing several publications and data supporting the safety of echocardiography contrast products in patients with cardiac shunts. Information concerning administration in patients with a cardiac shunt appears in the Warnings section of the DEFINITY Prescribing Information.
 
“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of DEFINITY, which has been used to perform more than seven million echocardiography studies,” said Cesare Orlandi, Chief Medical Officer at Lantheus. “The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to DEFINITY when undergoing cardiac ultrasound imaging.”
 
Neil Weissman, M.D., President of MedStar Health Research Institute (Washington, DC), Professor of Medicine at Georgetown University and Past President of the American Society of Echocardiography commented, “The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for DEFINITY in patients with cardiac shunts. This is particularly noteworthy as DEFINITY is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older.”
 
Dr. Weissman continued, “This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes.”
 
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RSNA
Radiology
DOI: http://dx.doi.org/10.1148/radiol.2016151732
Feb 1, 2017
 
Integration of Contrast-enhanced US into a Multimodality Approach to Imaging of Nodules in a Cirrhotic Liver: How I Do It
Authors: Patricia C. Jo, MD; Hyun-Jung Jang, MD; Peter N. Burns, PhD; Kelly W. Burak, MD; Tae Kyoung Kim, MD; Stephanie R. Wilson, MD
 
From the Department of Radiology (P.C.J., S.R.W.) and Department of Medicine, Division of Gastroenterology (K.W.B., S.R.W.), Foothills Medical Centre, University of Calgary, 1403 29 St NW, Calgary, AB, Canada T2N 2T9; Department of Medical Imaging, Toronto General Hospital, University of Toronto, Toronto, Ont, Canada (H.J.J., T.K.K.); and Department of Imaging Research, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont, Canada (P.N.B.).Address correspondence to S.R.W. (e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ).
 
Abstract
Accurate characterization of cirrhotic nodules and early diagnosis of hepatocellular carcinoma (HCC) are of vital importance. Currently, computed tomography (CT) and magnetic resonance (MR) imaging are standard modalities for the investigation of new nodules found at surveillance ultrasonography (US). This article describes the successful integration of contrast material–enhanced US into a multimodality approach for diagnosis of HCC and its benefits in this population. The application of contrast-enhanced US immediately following surveillance US allows for prompt dynamic contrast-enhanced evaluation, removing the need for further imaging of benign lesions. Contrast-enhanced US also provides dynamic real-time assessment of tumor vascularity so that contrast enhancement can be identified regardless of its timing or duration, allowing for detection of arterial hypervascularity and portal venous washout. The purely intravascular nature of US contrast agents is valuable as the rapid washout of nonhepatocyte malignancies is highly contributory to their differentiation from HCC. The authors believe contrast-enhanced US provides complementary information to CT and MR imaging in the characterization of nodules in high-risk patients.

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