Bracco Diagnostics Inc. and Amerinet Announce Group Purchasing Agreement to Include LumasonTM (sulfur hexafluoride lipid-type A microspheres) for Injectable Suspension for Contrast Echocardiography

MONROE TOWNSHIP, N.J.--()--Bracco Diagnostics Inc., the U.S. affiliate of Bracco Imaging, one of the world’s leading companies in the diagnostic imaging business, and Amerinet, a leading national healthcare solutions organization, announced today the expansion of its group purchasing agreement to include Lumason. Under the terms of the agreement, Amerinet’s membership base of more than 82,000 provider organizations across the U.S., will have access to Bracco’s Lumason for their contrast enhanced echocardiography needs.

Lumason, internationally known as SonoVue® which has been marketed for over 14 years in currently more than 30 countries worldwide, 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 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 proud to be a long-term Amerinet partner, and to offer Amerinet’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.”

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, Germany(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 Amerinet

As a leading national healthcare solutions organization, Amerinet collaborates with acute and non-acute care providers to create and deliver unique solutions through performance improvement resources, guidance and on-going support. With better product standardization and utilization, new financial tools beyond contracting and alliances that help lower costs, raise revenue and champion quality, Amerinet enriches healthcare delivery for its members and the communities they service. To learn more about how Amerinet can help you successfully navigate the future of healthcare reform, visit www.amerinet-gpo.com (http://www.amerinet-gpo.com).

Contacts

Bracco Diagnostics Inc.
Kimberly Gerweck, 609-514-2249
Kimberly.gerweck@diag.bracco.com

Release Summary

Bracco Diagnostics Inc. and Amerinet announced today the expansion of its group purchasing agreement to include Lumason™ to Amerinet's more than 82,000 provider organizations across the U.S

Contacts

Bracco Diagnostics Inc.
Kimberly Gerweck, 609-514-2249
Kimberly.gerweck@diag.bracco.com