MONROE TOWNSHIP, N.J., May 31, 2016 /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 its contrast enhanced ultrasound agent, LUMASON, has received the Innovative Technology designation from Vizient, Inc. the largest member-owned health care company in the country. Vizient's diverse membership and customer base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents almost $100 billion in annual purchasing volume.
The Innovative Technology designation was based on reviews of LUMASON by hospital experts who attended Vizient's Innovative Technology Expo in November 2015. The annual event provides medical technology suppliers with the opportunity to demonstrate their product and gain direct feedback from onsite clinical experts and healthcare providers on the impact their products may have on improving clinical care, safety, and benefits to an organization's care and business models.
"Vizient is committed to providing the members we serve with leading-edge technologies that deliver new clinical and operational benefits from what is currently available in the market today," said Debbie Archer, director of procurement for Vizient and leader of the Innovative Technology program for suppliers. "After reviewing Bracco Diagnostics Inc. and LUMASON at our annual Innovative Technology Expo, the hospital experts who attended agreed the product offers unique and incremental benefits over other products available on the market today, and recommended it for the Innovative Technology designation."
LUMASON has been approved by the U.S. Food and Drug Administration 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. LUMASON is also the first ultrasound contrast agent to obtain FDA approval for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients. Known globally as SonoVue®, which has been marketed for over 14 years in more than 40 countries, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect sound waves to enhance echocardiography.
With a proven safety and efficacy profile, LUMASON provides quality images and is packaged in a convenient three-part kit that does not require refrigeration or mechanical agitation. Each kit includes 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
"We are very pleased and proud to receive this designation by Vizient, and to offer Vizient's members and their healthcare professionals, the benefits of our contrast enhanced ultrasound agent," said Vittorio Puppo, CEO and President, Bracco Diagnostics Inc. "This offering further demonstrates our commitment to improve patient care in the United States."
In late 2015, the Centers for Medicare and Medicaid Services granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (OPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under OPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON among contrast agents used in ultrasound procedures.
Vizient is the new brand identity for the organizations formerly known as VHA Inc., University HealthSystem Consortium, Novation and MedAssets Spend and Clinical Resource Management. "Since 2003, more than 2,000 new and innovative products and technologies have been submitted through the Vizient's Innovative Technology program. Vizient works with member-led councils and task forces to identify and review potentially innovative products. If it is determined that a product is innovative, a contract may be awarded outside of Vizient's competitive bid cycle."
To learn more about Vizient's Innovative Technology program, visit https://www.novationco.com/expertise/technology/.
Please see Important Safety Information below.
INDICATIONS AND USAGE1
LUMASON is an ultrasound contrast agent indicated for use:
- 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
- in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
LUMASON is contraindicated in 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.
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
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.
LUMASON is 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, Germany (Mini-Spike).
SonoVue is a registered trademark of Bracco Suisse S.A.
LUMASON is a registered 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.; March 2016.
Please see full Prescribing Information including boxed WARNING at http://imaging.bracco.com/us-en/LUMASON.
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), and Nuclear Medicine through radioactive tracers. 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 Centers located in Italy, Switzerland, and the USA.
To learn more about Bracco Imaging, visit www.braccoimaging.com.
Bracco Diagnostics Inc.
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SOURCE Bracco Diagnostics Inc.