Cordis, a global leader in interventional cardiovascular technologies, announced today the initiation of the SELUTION Global Coronary Registry, set to be one of the largest real-world studies of drug-eluting balloon technology. The prospective registry will enroll up to 10,000 patients worldwide and track outcomes for the SELUTION SLR Drug-Eluting Balloon (DEB) over a five-year period.
The registry represents a significant expansion of the clinical evidence program for SELUTION SLR, which has already demonstrated promising results in pre-clinical and early clinical evaluations. According to Cordis, the device has shown sustained sirolimus presence in tissue for up to 90 days and favorable late lumen loss measurements in proof-of-concept studies.
"Drug-eluting balloons are one of the most interesting and exciting new technologies in the coronary interventional space," said Dr. Ajay J. Kirtane, Professor of Medicine at Columbia University Irving Medical Center and Director of the Columbia Interventional Cardiovascular Care Program, who will serve as Chairman of the registry's steering committee.
Dr. Kirtane emphasized the value of the registry approach: "The creation and initiation of this large real-world registry examining DEB utilization and the practice of PCI with this technology is a welcome development, which will help clinicians better understand where SELUTION SLR DEB can deliver the greatest benefits and improved outcomes in their practice."
Comprehensive Real-World Evidence Generation
The SELUTION Global Coronary Registry will complement five ongoing Level-1 randomized controlled trials. This multi-pronged evidence generation strategy underscores Cordis' commitment to developing robust clinical data to potentially change standard practice in coronary interventions.
The registry comes after recently reported positive results from peripheral vascular applications of the technology, which the company described as "extremely competitive and durable."
Dr. George Adams, Chief Medical Officer at Cordis, highlighted the company's evidence-focused approach: "The history of Cordis is grounded in a commitment to clinical evidence; putting patients first means backing our technology with the strongest evidence we can provide. The launch of the SELUTION Global Coronary Registry reaffirms this commitment."
Adams also noted that the company anticipates sharing "groundbreaking coronary results" in Fall 2025, suggesting confidence in the technology's performance.
International Expert Oversight
The registry will be guided by a steering committee of internationally recognized interventional cardiologists, bringing global expertise to the project. In addition to Dr. Kirtane as chairman, the committee includes:
- Professor Alexandre Abizaid, MD, PhD, Director of Interventional Cardiology at Incor – Universidade de Sao Paulo, Brazil
- Professor Robert Byrne, Director of Cardiology and Cardiovascular Research Institute (CVRI) Dublin, Mater Private Network; School of Pharmacy and Biomolecular Sciences, RCSI University, Ireland
- Dr. Nieves Gonzalo, Interventional Cardiologist, Hospital Clinico San Carlos, Spain
- Dr. Robert Yeh, Director of Richard A. and Susan F. Smith Center for Outcomes Research, Section Chief, Interventional Cardiology, Beth Israel Deaconess Medical Center, USA
Technology Designed to "Go Beyond Metal"
The SELUTION SLR DEB represents what Cordis describes as "the next generation of drug-eluting balloon technology." Currently commercially available in more than 40 countries, the device delivers sustained, predictable sirolimus release without leaving a permanent implant in the vessel.
This "leave nothing behind" approach potentially offers several advantages over traditional stenting, including preserving future treatment options and avoiding the long-term complications associated with permanent metallic implants.
The technology's design philosophy is captured in Cordis' tagline for the device: "Go Beyond Metal." This approach may be particularly valuable in anatomically challenging lesions, small vessels, bifurcations, and in-stent restenosis cases where additional metal layers are undesirable.
Implications for Interventional Cardiology
The launch of this extensive registry signals growing interest in drug-eluting balloon technology as a potential alternative to drug-eluting stents in certain clinical scenarios. By generating real-world evidence across diverse patient populations and practice settings, the registry may help define the optimal role of this technology in contemporary interventional cardiology.
For Cordis, a company with over 60 years in cardiovascular innovation, the registry also represents a strategic investment in building clinical evidence to support adoption of their technology in an increasingly evidence-driven healthcare environment.
The registry's five-year follow-up period will provide insights into the long-term durability of treatment effects, a critical consideration for interventional cardiologists weighing treatment options for patients with coronary artery disease.
