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.
“Since serving as a co-primary investigator in the first-in-human SELUTION study in India, I have followed its progress with great enthusiasm,” said Dr. Praveen Chandra, Chairman of Interventional Cardiology at Medanta – The Medicity, Gurugram, India. “These new results reaffirm what we saw early on—that the sirolimus drug-eluting balloon may offer an alternative to drug-eluting stents, reducing the need for permanent implants. It marks an important step forward in vessel-preserving coronary intervention.”
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.
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.
“We have been excited to share the SELUTION DeNovo and SELUTION4ISR clinical trial results with the medical community,” said Dr. George Adams, Chief Medical Officer, Cordis. “These studies will not only help clinicians evaluate the clinical value and safety of the SELUTION SLR DEB compared with the current therapy but will also guide cardiologists in understanding the role of drug-eluting balloons within the coronary treatment algorithm.”
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.
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