On December 1, 2025, an announcement was made regarding an exciting development for the treatment of coronary artery disease. The ‘Selution Iberia Registry,’ a real-life registry study in patients treated with the SELUTION SLRTM Sirolimus-eluting balloon, is set to commence. Sponsored by the Fundación EPIC, this registry has yet to start recruiting but holds promise for advancing interventional cardiology research. Professionals in clinical trials, regulatory affairs, and medical device development may find this news noteworthy.
What changed?
The Selution Iberia Registry was formally disclosed, detailing plans to investigate the real-world application of the SELUTION SLRTM sirolimus-coated balloon for treating coronary artery disease (CAD). As this study is still in its early phases, recruitment has not yet begun. This marks a pivotal moment for both research in cardiovascular diseases and the regulatory insights around emerging therapeutic devices.
What is the Selution Iberia Registry?
The clinical registry focuses on understanding the safety and effectiveness of the SELUTION SLRTM sirolimus-eluting balloon under real-world conditions. These devices deliver sirolimus, a drug proven to suppress restenosis, directly at the site of intervention via a balloon catheter system. While drug-eluting stents are widely utilized, drug-coated balloons offer an alternative suitable for specific patient populations, providing drug delivery without the need to implant permanent hardware.
Sponsored by Fundación EPIC, this registry aims to collect data that bridges clinical trial outcomes and real-world applications, providing robust information for regulators, clinicians, and device manufacturers. Professionals monitoring cardiovascular device performance and compliance will want to track its updates closely.
What does this mean for medical device professionals?
For professionals in clinical trials, regulatory affairs, and device manufacturing, the Selution Iberia Registry serves as an essential step toward expanding practical data on drug-coated balloons. These studies often move the needle on regulatory approvals, reimbursement policies, and device adoption processes worldwide.
Medical device companies may use findings to refine market-entry strategies and ensure compliance while demonstrating clinical and economic value for their products. The insights gained within this registry will likely influence Health Technology Assessments (HTAs) and evidence-based guidelines for interventional cardiology.
Frequently Asked Questions
1. What are sirolimus-coated balloons?
Sirolimus-coated balloons deliver an anti-proliferative drug, sirolimus, directly to a targeted area in blood vessels to reduce restenosis.
2. Is the trial currently recruiting patients?
No, the Selution Iberia Registry has not started recruiting participants yet.
3. Who is sponsoring this registry?
The Fundación EPIC is sponsoring the Selution Iberia Registry study.
Conclusion
The announcement of the Selution Iberia Registry opens doors for refining data sets around coronary artery disease management via sirolimus-coated balloons. Both regulators and industry professionals should monitor this study as it matures and delivers insights into practical applications for drug-device combination products. With recruitment pending, further updates from Fundación EPIC are expected.
Disclaimer
This article is intended for informational purposes and should not be interpreted as legal advice. Always consult appropriate regulatory guidance or professionals for compliance concerns.
Announcement Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07256249?term=medical+device