Introduction
CardioGen-82, a radioactive diagnostic agent produced by Bracco Diagnostics Inc., is used in positron emission tomography (PET) scans to evaluate myocardial perfusion in adult patients with suspected or existing coronary artery disease. This article provides an update on the clinical trials, market analysis, and projections for CardioGen-82, particularly in the context of its recent recall and subsequent efforts to return it to the market.
Clinical Trials and Safety Investigations
In 2011, the FDA issued a Drug Safety Communication alerting healthcare professionals to stop using CardioGen-82 due to potential increased radiation exposure in patients. This decision was prompted by reports of patients who had undergone PET scans with CardioGen-82 triggering radiation detectors at U.S. borders, indicating higher than expected levels of radiation[3][4][5].
Strontium Breakthrough
The primary issue identified was the "strontium breakthrough," where excessive concentrations of strontium-82 (Sr-82) and strontium-85 (Sr-85) were found in the generator eluates. This breakthrough led to increased radiation exposure in some patients. However, the FDA and Bracco Diagnostics Inc. concluded that this excessive exposure was unlikely to pose significant risks to patients[1].
Clinical Studies and Testing
Bracco conducted extensive clinical studies and testing to assess the extent of patient exposure. For instance, a study involving 375 patients at 43 clinical sites found that 54 patients from two sites required further radiation testing due to abnormal screening results. These sites had insufficient documentation of compliance with the recommended strontium breakthrough testing[1].
Quality Control and Manufacturing Review
As part of the recall process, all recalled generators were sent back to the manufacturer for functional and breakthrough testing. The testing showed that the generators had Sr-82 and Sr-85 levels within specification limits. Bracco also re-qualified all CardioGen components and revalidated the manufacturing process at the FDA's request[5].
Market Analysis
Recall and Reintroduction
The voluntary recall of CardioGen-82 in July 2011 significantly impacted its market presence. However, Bracco Diagnostics Inc. has been working closely with the FDA to address the issues and plan a phased reintroduction of the product. The company proposed a controlled and phased reintroduction, which received FDA support, with data collection and evaluation of field use beginning in the first quarter of 2012[3][5].
Enhanced Labeling and User Training
To ensure proper use and minimize the risk of strontium breakthrough, Bracco has enhanced the labeling and user training for CardioGen-82. This includes implementing a new quality control data repository and monitoring program, as well as on-site reviews of facilities' daily quality control records to reinforce customer training and education[5].
Market Impact
The recall and subsequent efforts to reintroduce CardioGen-82 have had a temporary impact on the market for cardiac PET radiopharmaceuticals. However, with the FDA's support and Bracco's commitment to enhancing safety and quality control, the product is expected to regain its market share. The introduction of a new infusion system in 2020, designed to enhance automation, efficiency, and simplicity, further supports the product's market potential[2].
Projections
Market Reentry
Bracco anticipates that shipments of CardioGen-82 will resume by the end of the first quarter following the recall. The phased reintroduction plan, which includes enhanced labeling, user training, and quality control measures, is expected to restore confidence in the product among healthcare professionals and patients[3][5].
Future Developments
The new infusion system introduced in 2020 is expected to improve the overall efficiency and safety of using CardioGen-82. This system, with its intuitive and ergonomic design, minimizes radiation exposure and provides easy access to all system components, which should further enhance the product's market position[2].
Competitive Landscape
In the market for cardiac PET radiopharmaceuticals, CardioGen-82 faces competition from other diagnostic agents. However, its unique characteristics, such as the ability to discover mild degrees of ischemia through PET imaging, position it as a valuable tool in nuclear cardiology. With the enhancements and safety measures being implemented, CardioGen-82 is likely to remain a significant player in this market[3].
Key Takeaways
- Clinical Trials and Safety: Extensive clinical studies and testing have been conducted to address the strontium breakthrough issue, ensuring patient safety.
- Market Analysis: The recall had a temporary impact, but with FDA support and enhanced safety measures, CardioGen-82 is expected to regain its market share.
- Projections: Phased reintroduction, new infusion system, and enhanced labeling and training are projected to restore and grow the product's market presence.
FAQs
What is CardioGen-82 used for?
CardioGen-82 is a radioactive diagnostic agent used in PET scans to evaluate myocardial perfusion in adult patients with suspected or existing coronary artery disease.
Why was CardioGen-82 recalled?
CardioGen-82 was recalled due to reports of patients receiving higher than expected levels of radiation, attributed to a "strontium breakthrough" from the radiotracer generator.
What measures have been taken to address the safety concerns?
Bracco Diagnostics Inc. has conducted extensive clinical studies, re-qualified all components, revalidated the manufacturing process, and enhanced labeling and user training to ensure proper use and minimize risks.
When is CardioGen-82 expected to return to the market?
Shipments of CardioGen-82 are anticipated to resume by the end of the first quarter following the recall, with a phased reintroduction plan.
What are the new developments in the CardioGen-82 infusion system?
A new infusion system was introduced in 2020, designed to enhance automation, efficiency, and simplicity, while minimizing radiation exposure.
Sources
- FDA Drug Safety Communication: "Update: Preliminary Findings from Ongoing Investigations of CardioGen-82" - FDA.
- Bracco Diagnostics Inc.: "Bracco Diagnostics Inc. Introduces New CardioGen-82® (Rubidium Rb-82 Generator) Infusion System" - PR Newswire.
- AuntMinnie: "Bracco to return CardioGen PET tracer to market in Q1" - AuntMinnie.
- ITN Online: "Bracco Updates Status of CardioGen-82 Recall, Third Patient Being Tested" - ITN Online.
- DICardiology: "Plans Made for Market Reintroduction of CardioGen-82" - DICardiology.
