#USA #Miami Lakes #Cordis #SELUTION SLR #CAD Treatments

Cordis Revolutionizes Treatments for Coronary Artery Disease

At the recent Transcatheter Cardiovascular Therapeutics® (TCT®) 2025 symposium, Cordis showcased remarkable progress in treating coronary artery disease (CAD) through its SELUTION DeNovo and SELUTION4ISR clinical trials. These randomized trials demonstrate that Cordis' SELUTION SLR™ Drug-Eluting Balloon (DEB) strategy provides effective alternatives to conventional drug-eluting stents (DES), potentially reshaping the landscape of cardiovascular intervention.

SELUTION DeNovo Trial: A Pioneering Study

The SELUTION DeNovo trial marks a significant milestone as the largest randomized trial of drug-eluting balloons to date. Conducted with a diverse cohort of 3,323 patients across 62 global sites, this study compared the SELUTION SLR™ DEB with standard DES treatment strategies in real-world scenarios involving coronary de novo lesions. The trial's results were compelling, showing a non-inferiority rate wherein the target vessel failure (TVF) at 12 months was 5.3% for SELUTION SLR™ DEB compared to 4.4% for DES.

Professor Christian Spaulding, Co-Principal Investigator at Hôpital Européen Georges-Pompidou, emphasized the significance of these findings, stating, "The SELUTION SLR™ DEB achieved results comparable to those of drug-eluting stents while reducing the need for stents." This minimal stenting approach not only underscores the potential for better patient outcomes but also opens doors for alternative treatment options in the future.

SELUTION4ISR Trial: Addressing In-Stent Restenosis

In tandem with the SELUTION DeNovo trial, the SELUTION4ISR study focused on patients experiencing in-stent restenosis (ISR). This prospective, multicenter, randomized controlled trial provided a benchmark against the standard care for ISR treatment. The trial indicated that SELUTION SLR™ DEB achieved a target lesion failure (TLF) rate of 15.2%, compared to 13.5% for the standard treatment, which included 80% drug-eluting stents.

Dr. Roxana Mehran, Co-Principal Investigator at Icahn School of Medicine at Mount Sinai, reinforced the necessity of such innovations, noting, "With the sirolimus-based SELUTION SLR™ DEB, clinicians can now offer a proven treatment option that balances efficacy and the avoidance of additional metallic layers, a common challenge in treating ISR."

A Commitment to Innovation

The successful outcomes of both trials underscore Cordis' long-standing commitment to advancing cardiovascular care. By meeting the primary endpoints of both studies, Cordis paves the way for a broader adoption of drug-eluting balloon therapies in Percutaneous Coronary Intervention (PCI) strategies.

With over 17,000 patients involved in the SELUTION SLR™ DEB clinical portfolio, Cordis continues to lead the charge in innovative medical solutions, improving patient experiences and health outcomes across the globe. Dr. Martin Leon, Chair of the Cordis Clinical Advisory Board, praised Cordis for its groundbreaking efforts: "These trials signify a leap forward in the field of coronary intervention, offering a safe and effective alternative to traditional DES treatments."

The Future of Coronary Intervention

Currently available in over 65 countries and under investigation in the U.S., the SELUTION SLR™ DEB is characterized by its Sustained Limus Release (SLR) technology. This innovative approach is designed to offer controlled and sustained drug release for up to 90 days, efficiently addressing the restenosis cascade that often complicates coronary interventions.

As Cordis gears up for subsequent clinical trials to further its mission of delivering pioneering cardiovascular treatments, the results from the SELUTION DeNovo and SELUTION4ISR trials serve as a cornerstone for future initiatives. These studies are not only a testament to the effectiveness of advanced medical technology but also highlight Cordis' dedication to transforming the landscape of cardiovascular treatment for the benefit of patients worldwide.