Cordis Unveiled Breakthrough Results from SELUTION DeNovo and SELUTION4ISR Randomized Trials at TCT 2025, Transforming Coronary Artery Disease (CAD) Treatment Beyond Stenting

• SELUTION DeNovo Trial - the largest randomized Drug Eluting Balloon trial - demonstrates a SELUTION SLR™ DEB strategy is non-inferior to a Drug Eluting Stent treatment strategy in de novo lesions.
• SELUTION4ISR, a randomized controlled trial, proves SELUTION SLR™ DEB is an alternative to current standard of care for In-Stent Restenosis (ISR) treatment.

MIAMI LAKES, Fla., Oct. 26, 2025 /PRNewswire/ -- Cordis, a global leader in interventional cardiovascular technology, today announced the groundbreaking results from the SELUTION DeNovo and SELUTION4ISR trials at Transcatheter Cardiovascular Therapeutics^® (TCT^®) 2025, the annual scientific symposium of the Cardiovascular Research Foundation^® (CRF^®).

Both randomized clinical trials demonstrated positive outcomes that met primary endpoints for the SELUTION SLR™ Drug-Eluting Balloon (DEB) compared to the current standard of care in treating de novo and ISR coronary lesions. These results highlight SELUTION SLR™ DEB as a compelling alternative to drug-eluting stents (DES), offering physicians the ability to minimize the need for stents.

SELUTION DeNovo Trial: Randomized with 3,323 Patients Across 62 Sites and Demonstrated Non-Inferiority to a DES strategy

In the highly anticipated SELUTION DeNovo trial, a SELUTION SLR™ DEB treatment strategy in real-world coronary de novo lesions was compared to the current standard of care, a systematic DES treatment strategy. With 3,323 patients enrolled across 62 international sites, it is the largest randomized coronary DEB trial to date. The SELUTION SLR™ DEB treatment strategy demonstrated non-inferiority to a DES treatment strategy with target vessel failure (TVF) at 12-months of 5.3% as compared to the DES arm with 4.4%.  Evidence from this study supports a SELUTION SLR™ DEB treatment strategy of de novo lesions as an alternative to traditional DES treatment.  

"These findings signal a paradigm shift in how we approach Percutaneous Coronary Intervention," said Co-Principal Investigator, Professor Christian Spaulding, Hôpital Européen Georges-Pompidou, Paris, France. "SELUTION SLR™ DEB achieved results comparable to drug-eluting stents while reducing the need for stents.  With this minimal stenting approach, patients can benefit from an effective and safe sirolimus drug-eluting balloon treatment today, while keeping more options available for tomorrow."  

SELUTION4ISR Trial: Enrolled Patients Across Diverse Global Sites and Confirms Non-Inferiority to Standard of Care

The SELUTION4ISR trial, a prospective, multicenter, randomized controlled study evaluating SELUTION™ SLR DEB in patients with coronary in-stent restenosis, demonstrated non-inferior performance against ISR standard-of-care treatment. Target lesion failure (TLF) at 12-months was 15.2% with SELUTION SLR™ DEB vs. 13.5% in standard of care control which was comprised of 80% DES. These results will be leveraged to support a submission to FDA for coronary ISR indication of the device.

"With the sirolimus-based SELUTION SLR™ DEB, clinicians now have a proven option that delivers durable efficacy while avoiding additional metal layers and the long-term challenges they pose in treating ISR," said Co-Principal Investigator, Dr. Roxana Mehran, Icahn School of Medicine at Mount Sinai, New York, USA.

The evidence from these two groundbreaking trials presented at TCT^® on the SELUTION SLR™ DEB represents Cordis' enduring commitment to innovation in cardiovascular intervention. By meeting the primary endpoints in both the SELUTION4ISR and SELUTION DeNovo trials, Cordis is poised to lead the expansion of drug-eluting balloon use within Percutaneous Coronary Intervention (PCI) treatment strategies. Cordis looks forward to continuing clinical investigations to elevate the standard of care and deliver meaningful innovations for patients. With the SELUTION SLR™ DEB clinical portfolio that includes more than 17,000 patients, Cordis remains committed to advancing science and innovation through collaboration—transforming the way physicians treat patients.

"I applaud Cordis for again moving the coronary interventional field forward with the successful SELUTION DeNovo and SELUTION4ISR trials. These trials demonstrate safe and efficacious results for SELUTION SLR™ DEB in treating complex de novo and ISR lesions, providing a real alternative to a DES," said Dr. Martin Leon, Chair of the Cordis Clinical Advisory Board, Professor of Medicine at Columbia University Irving Medical Center & Chief Innovation Officer and Director of the Cardiovascular Data Science Center for the Division of Cardiology.

About SELUTION SLR™ DEB

Commercially available in more than 65 countries, and investigational in the U.S., SELUTION SLR™ DEB stands out for its Sustained Limus Release (SLR) technology, which is designed to provide controlled and sustained drug release through 90-days, covering the restenosis cascade.

About Cordis

From the first guidewire to the first drug-eluting stent, Cordis has been at the heart of cardiovascular innovation for more than 60 years. Today, Cordis drives transformation through internal development, Cordis-X partnerships, and strategic acquisitions—powered by a global footprint and deep operational expertise. With a focus on better clinical outcomes, customer-centered service, and impactful education, Cordis will go beyond to relentlessly pursue its mission to transform cardiovascular care.

Media Contact:

Kelly May
Director, Corporate Communications
Cordis
[email protected]
www.cordis.com

SOURCE Cordis