"Following our long-term efforts and commitment in cardiac PET, we are pleased to see that the joint Position Statement of ASNC and SNMMI provides an evidence-based, expert consensus on the reliability and important clinical benefits of myocardial perfusion PET in the assessment and management of patients with known or suspected CAD", said Dr. Alberto Spinazzi, BDI Senior Vice President, Global Medical and Regulatory Affairs. "We believe the recommendations advanced by ASNC and SNMMI are very much in line with the goals of the Centers for Medicare & Medicaid Services to guarantee effective, safe, efficient, patient-centered, and timely care."
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 USA. To learn more about Bracco Imaging, visit www.braccoimaging.com.
IMPORTANT SAFETY INFORMATION:
WARNING: UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85) RADIATION EXPOSURE
Unintended radiation exposure occurs when the levels of Sr-82 or Sr-85 in the rubidium Rb 82 chloride injection exceed specified limits [see Warnings and Precautions (5.1)].
Perform generator eluate tests:
1) Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume [see Dosage and Administration (2.4)].
2) Determine Rb-82, Sr-82, Sr-85 levels in the eluate:
- Once daily, prior to any drug administrations, and
- At additional daily tests after detection of an Alert Limit. Alert Limits are:
- 14 L for the generator's cumulative eluate volume, or
- An eluate Sr-82 level of 0.002 μCi/mCi Rb-82, or
- An eluate Sr-85 level of 0.02 μCi/mCi Rb-82.
- Perform the additional daily tests at time points determined by the day's elution volume; tests are performed every 750 mL [see Dosage and Administration (2.5)].
3) Stop use of a generator at an Expiration Limit of:
- 17 L for the generator's cumulative eluate volume, or
- 42 days post generator calibration date, or
- An eluate Sr-82 level of 0.01 μCi/mCi Rb-82, or
- An eluate Sr-85 level of 0.1 μCi/mCi Rb-82 [see Dosage and Administration (2.6)].
Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress testing in accordance with the pharmacologic stress agent's prescribing information and only in the setting where cardiac resuscitation equipment and trained staff are readily available.
Please consult full Prescribing Information for CardioGen-82 contained at http://imaging.bracco.com/sites/braccoimaging.com/files/technica_sheet_pdf/Cardiogen%20Full%20Prescribing%20Information.pdf
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/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.
i American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging Joint Position Statement on the Clinical Indications for Myocardial Perfusion PET. J Nucl Cardiol. 2016 Aug 15. [Epub ahead of print] DOI: 10.1007/s12350-016-0626-9
Bracco Diagnostics Inc.
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SOURCE Bracco Diagnostics Inc.