MONROE TOWNSHIP, N.J.--(BUSINESS WIRE)--Bracco Imaging, through its affiliate Bracco Diagnostics Inc., announced today that the first echocardiography imaging procedure with LumasonTM (sulfur hexafluoride lipid-type A microspheres) was performed last month at Morristown Medical Center, part of the Atlantic Health System, in New Jersey, U.S.A. This is the first administration after the development of the agent in the United States and approval by the United States Food and Drug Administration.
“Now we have an additional option when performing contrast enhanced ultrasound.”
“We’re thrilled to be the first medical center to use Lumason in adults with suboptimal echocardiograms,” said Linda Gillam, MD, MPH, FASE, chair of the Gagnon Cardiovascular Institute at Morristown Medical Center. “Now we have an additional option when performing contrast enhanced ultrasound.”
Lumason, internationally known as SonoVue® in 40 countries, is an ultrasound contrast agent made up of gas-filled microbubbles (or microspheres) that reflect the sound waves to enhance the image.
Lumason has been approved by the U.S. Food and Drug Administration (FDA) in the U.S. for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
“We are very proud that U.S. healthcare professionals can now also count on the benefits of our contrast enhanced ultrasound agent,” said Fulvio Renoldi Bracco, Head of Global Business Unit Imaging at Bracco. “The launch of Lumason confirms our commitment to improve patient care in the United States.”
Lumason is supplied as a three-part kit. 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
For additional information about Lumason, please contact Bracco Diagnostics at: Services.Professional@diag.bracco.com
Please see Important Safety Information below.
INDICATIONS1
Lumason is an ultrasound contrast agent 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.
CONTRAINDICATIONS1
Do not administer Lumason to patients with:
- known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
- history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
Do not administer by intra-arterial injection.
IMPORTANT SAFETY INFORMATION1
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)].
- Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)].
- Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].
The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1) ].1
1 Please see full Prescribing Information including boxed WARNING at http://imaging.bracco.com/us-en/lumason
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse SA, Plan-les-Ouates Geneve, Switzerland (Lumason lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, (Mini-Spike).
SonoVue is a registered trademark of Bracco Suisse S.A.
Lumason is a trademark of Bracco Diagnostics Inc.
1.Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; October 2014.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world’s leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), Nuclear Medicine through radioactive tracers, and Gastrointestinal Endoscopy. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.
The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.
Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.
Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centres located in Italy, Switzerland, and USA.
To learn more about Bracco Imaging, visit www.braccoimaging.com.
About Morristown Medical Center
Morristown Medical Center, located in Morristown, NJ, is part of Atlantic Health System, one of the largest non-profit health care systems in New Jersey. Accredited by The Joint Commission, the hospital was recognized by U.S. News & World Report in 2014 as a top hospital nationwide for cardiology and heart surgery, gynecology, geriatrics, orthopedics and pulmonology. Morristown Medical Center also ranked as a “Best Regional Hospital” for cancer, diabetes & endocrinology, neurology and neurosurgery, as well as gastroenterology & GI Surgery, nephrology and urology. In May 2015, U.S. News & world Report, in its first Hospital Ratings in Common Care, named Morristown Medical Center one of only 38 hospitals in the nation to rank “High Performing” in all five areas, which included hip replacement, knee replacement, heart bypass surgery, congestive heart failure and chronic obstructive pulmonary disease (COPD). The Gagnon Cardiovascular Institute at Morristown Medical Center encompasses the largest cardiovascular program in New Jersey, performing more than 1,500 heart surgeries annually, more than any other cardiovascular facility in the state. Morristown Medical Center is verified as a Level I Regional Trauma Center by the American College of Surgeons and designated a Level II by the state of New Jersey and was re-designated a Magnet Hospital for Excellence in Nursing Service, the highest level of recognition by American Nurses Credentialing Center for facilities that provide acute care services, a distinction awarded to less than five percent of U.S. hospitals. To learn more about Morristown Medical Center, please visit http://www.atlantichealth.org/morristown.
All trademarks and registered trademarks are the property of their respective owners.
Contacts
Press:
Bracco Diagnostics Inc.
Lakshmi Sundar, 609-514-2236
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