Cordis, a global leader in interventional cardiovascular technology, announced results from two major clinical trials — SELUTION DeNovo and SELUTION4ISR — presented at Transcatheter Cardiovascular Therapeutics (TCT) 2025, the annual scientific symposium of the Cardiovascular Research Foundation (CRF).
Both randomized controlled trials met their primary endpoints, demonstrating that the SELUTION SLR™ Drug-Eluting Balloon (DEB) is non-inferior to the current standard of care using Drug-Eluting Stents (DES) in the treatment of de novo and in-stent restenosis (ISR) coronary lesions.
The SELUTION DeNovo trial enrolled 3,323 patients across 62 international sites, making it the largest randomized coronary DEB study to date. The trial compared a SELUTION SLR™ DEB treatment strategy with a DES-based strategy in real-world coronary de novo lesions.
At 12 months, the target vessel failure (TVF) rate was 5.3% in the DEB group compared with 4.4% in the DES group, confirming non-inferiority of the DEB strategy.
“These findings signal a paradigm shift in how we approach percutaneous coronary intervention,” said Professor Christian Spaulding, Co-Principal Investigator, Hôpital Européen Georges-Pompidou, Paris. “SELUTION SLR™ DEB achieved results comparable to drug-eluting stents while reducing the need for stents, offering patients an effective and safe sirolimus-based balloon treatment today, with more flexibility for the future.”
The SELUTION4ISR trial, a prospective, multicenter randomized controlled study, evaluated SELUTION SLR™ DEB in patients with coronary in-stent restenosis (ISR). The trial demonstrated non-inferior performance compared to the standard-of-care treatment, which was composed of approximately 80% DES use.
At 12 months, the target lesion failure (TLF) rate was 15.2% in the DEB group versus 13.5% in the control group. These results will support an upcoming FDA submission for coronary ISR indication of the device.
“With the sirolimus-based SELUTION SLR™ DEB, clinicians now have a proven option that delivers durable efficacy without adding new metal layers,” said Dr. Roxana Mehran, Co-Principal Investigator, Icahn School of Medicine at Mount Sinai, New York.
Cordis highlighted that the positive outcomes from both SELUTION DeNovo and SELUTION4ISR trials reinforce the company’s commitment to advancing drug-eluting balloon therapy as part of percutaneous coronary intervention (PCI) strategies.
“These trials demonstrate safe and effective results for SELUTION SLR™ DEB in treating complex de novo and ISR lesions, providing a real alternative to DES,” said Dr. Martin Leon, Chair of the Cordis Clinical Advisory Board and Professor of Medicine at Columbia University Irving Medical Center.
Cordis plans to leverage data from its SELUTION SLR™ DEB clinical portfolio, which now includes more than 17,000 patients, to expand DEB use globally and pursue new regulatory approvals.
The SELUTION SLR™ DEB features Sustained Limus Release (SLR) technology, designed to provide controlled sirolimus delivery over 90 days to address the entire restenosis cascade. The device is commercially available in over 65 countries and remains investigational in the United States.
Cordis has been at the forefront of cardiovascular innovation for more than 60 years, from developing the first guidewire to pioneering drug-eluting stent technology. The company continues to advance interventional care through internal development, Cordis-X partnerships, and strategic acquisitions, with a focus on clinical outcomes, customer-centric service, and global education.