Teleflex’s Ringer™ PBC IDE Study Preliminary Results: A New Development in Interventional Cardiology
Wayne, PA, March 27, 2025 – Teleflex Incorporated, a pioneering global medical technology company, recently unveiled the preliminary findings from its Ringer™ Percutaneous Biliary Drainage (PBC) IDE (Investigational Device Exemption) study during the CTO Plus Conference in New York. The study was presented by its principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief of Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer, and Director of Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.
Background on the Ringer™ PBC IDE Study
The Ringer™ PBC IDE study is a pivotal trial designed to assess the safety and efficacy of the Ringer™ PBC system, a novel, fully-covered, self-expanding, and fully-retrievable biliary drainage system. The system is intended to improve the treatment of biliary complications in patients undergoing interventional procedures.
Preliminary Findings from the Ringer™ PBC IDE Study
According to Kandzari’s presentation, the preliminary results of the Ringer™ PBC IDE study demonstrated a high rate of technical success, with 98.5% of the procedures completed successfully. The system also showed impressive clinical outcomes, including a low rate of adverse events, such as bile leaks (1.5%), and no instances of device migration or cholangitis. These outcomes are significant improvements compared to the current standard of care and could potentially change the way biliary complications are managed in interventional procedures.
Impact on Patients
For patients undergoing interventional procedures, the Ringer™ PBC system’s preliminary results could translate into several benefits, including:
- Reduced risk of complications, such as bile leaks and cholangitis, which can lead to increased patient safety and shorter hospital stays.
- Improved patient comfort due to the fully-covered design, which eliminates the need for external drainage bags and external catheters.
- Enhanced procedural efficiency, as the system can be left in place for extended periods, reducing the need for multiple procedures and follow-up visits.
Impact on the World
The potential impact of the Ringer™ PBC system on the medical community and the world at large extends beyond individual patients:
- Cost savings: The reduced need for multiple procedures and follow-up visits could lead to substantial cost savings for healthcare systems and insurers.
- Improved patient outcomes: The improved safety and efficacy of the Ringer™ PBC system could lead to better patient outcomes and overall improved quality of care.
- Innovation in interventional cardiology: The Ringer™ PBC system represents a significant step forward in interventional cardiology, showcasing the potential for innovative medical technologies to improve patient care and outcomes.
Conclusion
In conclusion, the preliminary results from Teleflex’s Ringer™ PBC IDE study, as presented at the CTO Plus Conference, represent a promising development in the field of interventional cardiology. The findings suggest that the Ringer™ PBC system could significantly improve patient safety, comfort, and procedural efficiency, while also potentially leading to cost savings and better overall patient outcomes. As the study progresses, it will be essential to closely monitor its results and the potential impact on the medical community and beyond.
Stay tuned for further updates on this exciting development in interventional cardiology and the potential benefits it could bring to patients and the world.
