Cordis Reports Positive Phase 3 Data from SELUTION DeNovo and SELUTION4ISR Trials at TCT 2025

Cordis announced positive results from two pivotal randomized clinical trials — SELUTION DeNovo and SELUTION4ISR, presented at Transcatheter Cardiovascular Therapeutics (TCT) 2025, the annual scientific symposium of the Cardiovascular Research Foundation (CRF). Both studies met their primary endpoints, supporting the SELUTION SLR Drug-Eluting Balloon (DEB) as a potential alternative to conventional drug-eluting stents (DES) in treating coronary artery disease.

SELUTION DeNovo: Largest Randomized Coronary DEB Trial

The SELUTION DeNovo trial enrolled 3,323 patients across 62 global sites, making it the largest randomized coronary DEB study to date. It compared a SELUTION SLR DEB treatment strategy for real-world de novo coronary lesions against the standard DES approach.

At 12 months, target vessel failure (TVF) occurred in 5.3% of patients in the DEB arm versus 4.4% in the DES arm, meeting the criterion for non-inferiority. Investigators noted the results support SELUTION SLR DEB as a stent-free alternative for suitable de novo lesions.

“Since serving as co-primary investigator in the first-in-human SELUTION study in India, I’ve followed its progress closely,” said Dr. Praveen Chandra, Chairman of Interventional Cardiology at Medanta – The Medicity, Gurugram. “These new results reaffirm that sirolimus drug-eluting balloons may reduce the need for permanent implants, marking a significant step forward in vessel-preserving coronary intervention.”

SELUTION4ISR: Non-Inferior Results in In-Stent Restenosis

The SELUTION4ISR trial evaluated SELUTION SLR DEB in patients with coronary in-stent restenosis (ISR). The study met its non-inferiority endpoint, showing target lesion failure (TLF) at 12 months in 15.2% of DEB-treated patients versus 13.5% in the control group, which consisted primarily (80%) of DES-treated cases.

Broader Clinical Significance

Together, the two trials strengthen clinical evidence supporting drug-eluting balloons as a viable tool within percutaneous coronary intervention (PCI) strategies, particularly for patients where avoiding stent placement is desirable.

“These studies will help clinicians evaluate the clinical value and safety of the SELUTION SLR DEB compared with current therapy,” said Dr. George Adams, Chief Medical Officer at Cordis. “They also provide guidance for understanding how DEBs fit into future coronary treatment algorithms.”

Expanding the DEB Evidence Base

The SELUTION SLR DEB features Sustained Limus Release (SLR) technology, designed to deliver controlled sirolimus release over 90 days — a period aligned with the restenosis cascade. The company’s ongoing clinical program includes over 17,000 patients, spanning coronary and peripheral indications.

Commercially available in more than 65 countries and currently investigational in the U.S., SELUTION SLR DEB represents a key pillar of Cordis’ cardiovascular innovation portfolio. The company plans to continue expanding clinical research and advancing DEB adoption across interventional cardiology.

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