Bracco Diagnostics Inc. Announces New Partnership to Increase Access to Cardiac PET Imaging

MONROE TOWNSHIP, N.J., March 29, 2021 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced today a new partnership with CardioNavix, LLC aimed at improving patient access to cardiac PET imaging, an important diagnostic test for the detection of coronary artery disease (CAD). This new program, the Bracco Mobile Isotope Service, will enable more patient care sites, such as community hospitals, physician practices and outpatient imaging centers, to provide cardiac PET imaging.

Kim McDaniel, Sr. Director, Nuclear Medicine Sales and Market Support said, "Establishing a cardiac PET imaging program requires significant upfront and ongoing costs that a provider must be able to recover. This can make the modality challenging to implement for institutions with lower patient volumes due to location or the need to share equipment with oncology studies. This new program will help lower the upfront cost and business risk, to allow more healthcare providers to offer this important diagnostic test. Our Bracco Mobile Isotope Service and partnership with CardioNavix is another example of our commitment to increase patient access to cardiac PET imaging."

Bracco Mobile Isotope Service On-Demand Delivery Program Increases Flexibility, Decreases Upfront Business Risk
Bracco has traditionally offered CardioGen-82^® (Rubidium Rb 82 Generator) and its accompanying infusion system to its more than 270 customer sites at a per-generator fixed cost, with several options for delivery schedules. These options work best for most sites, those with enough patient procedures to justify the fixed cost. For sites just starting out or with lower patient volumes, the fixed cost is sometimes prohibitive.

The Bracco Mobile Isotope Service with CardioNavix provides a solution with on-demand generator delivery service, expanding access to patient care sites with low volume. The generator and all necessary equipment are delivered as needed, so the site pays only for the days they wish to image patients. It can be ideal for healthcare providers imaging on a part-time schedule, or those located in less populous areas. It also allows sites to ramp up and grow into a full-time traditional generator delivery schedule as their number of procedures increases.

Lon Wilson, President and Radiation Safety Officer of CardioNavix, explains, "Cardiac PET imaging is recognized as the test of choice for non-invasive cardiac perfusion imaging. It meets important goals for the Centers for Medicare and Medicaid Services (CMS) including supporting positive patient outcomes with lower cost and high patient satisfaction. We are thrilled to partner with Bracco Diagnostics to deliver cardiac PET to imaging labs nationwide. Expanding access to cardiac PET imaging by lowering the financial barriers to entry is a win-win for healthcare providers and their patients. We anticipate significant interest in the program and believe that our agreement with Bracco Diagnostics will help more providers offer cardiac PET imaging to their patients."

Bracco and CardioNavix LLC: Committed to Patient Care
Since the late 1980s, Bracco has invested in cardiac PET imaging through research, innovation and clinical excellence. Founded in 2017, CardioNavix has made it their mission to safely and securely provide on-demand Rubidium Rb82 generators to support imaging for underserved markets. Together, they will expand patient care and access to accurate, efficient cardiac PET imaging, and be able to tailor the right program for any healthcare provider.

Indications and Usage for CARDIOGEN-82^® (Rubidium Rb 82 Generator)
CARDIOGEN-82^® (Rubidium Rb 82 Generator) is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

IMPORTANT SAFETY INFORMATION:

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOWTHE ELUATE TESTING PROTOCOL
Please see full prescribing information for complete boxed warning

High Level Radiation Exposure with Use of Incorrect Eluent
Using the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels (5.1)

• Use only additive-free 0.9%Sodium Chloride Injection USP to elute the generator (2.5)
• Immediately stop the patient infusion and permanently discontinue the use of the affected CARDIOGEN-82 generator if the incorrect solution is used to elute the generator (4)
• Evaluate the patient's radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.10)

Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol
Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed limits. (5.2)

• Record eluate volume, including waste and test volumes. (2.5)
• Strictly adhere to the generator eluate testing protocol (2.6, 2.7)
• Stop using the generator if it reaches any of its Expiration Limits (2.8)

Please see full Prescribing Information for CARDIOGEN-82 (Rubidium Rb 82 Generator) including boxed WARNING at https://imaging.bracco.com/us-en/products/nuclear-medicine-radiopharmaceuticals/cardiogen-82.

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.

CARDIOGEN-82 is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by GE Healthcare, Medi-Physics, Inc., South Plainfield, NJ 07080.

CARDIOGEN-82 is a registered trademark of Bracco Diagnostics Inc.

About CardioNavix
CardioNavix, located in Wexford, Pennsylvania, provides healthcare facilities with daily on-demand Rubidium-82 infusion systems for cardiac PET imaging.

CardioNavix recognizes the need for a Rubidium-82 generator for flexible use and possesses the versatility to have the infusion system there on the days you need it and not on the days you don't - including weekends.

CardioNavix is the only company in the nation equipped to deliver the CardioGen-82® infusion system to healthcare facilities for daily use with its patented transport device.  CardioNavix has helped hundreds of physicians and hospitals successfully introduce cardiac PET imaging to their patient care sites.

A first in the industry, CardioNavix supports medical providers who may not have the necessary volume of studies for a full-time on-site generator to now provide the most advanced non-invasive perfusion study available to their patients.

To learn more about CardioNavix, visit www.cardionavix.com.

For additional information about Bracco's products, and for full prescribing information, please visit https://imaging.bracco.com/us-en. 

About Bracco Imaging S.p.A.
Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider, headquartered in Milan, Italy.

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 and novel PET imaging agents. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. Bracco Imaging has a strong presence in key geographies: North America, China, Europe, Japan, Brazil, Mexico and South Korea.

Bracco Imaging's manufacturing plants operate in full compliance with the best practices and sustainable eco-friendly production processes. Manufacturing sites are based in Italy, Switzerland, Germany, Canada, China, Japan, and the USA.

Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in three centers based in Italy, Switzerland and the USA. To learn more about Bracco Imaging, visit www.braccoimaging.com.

Press Contact:
Kimberly Gerweck
Bracco Diagnostics Inc. Media Relations (USA)
[email protected]
D: +1 609-524-2777

SOURCE Bracco Diagnostics Inc.