SELUTION SLR™ Drug-Eluting Balloon Approved by FDA for In-Stent Restenosis: First and Only Sirolimus Drug-Eluting Balloon in the US

SELUTION SLR™ Drug-Eluting Balloon Approved by FDA for In-Stent Restenosis: First and Only Sirolimus Drug-Eluting Balloon in the US

Cordis, a global leader in interventional cardiovascular and endovascular technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR), marking a major milestone in expanding treatment options for one of the most complex challenges in interventional cardiology. Physicians now have immediate access to the SELUTION SLR™ DEB, a next-generation drug-eluting balloon designed to deliver sustained sirolimus therapy without leaving a permanent implant behind.

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“FDA approval of the SELUTION SLR™ DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care,” said Matt Muscari, President of Americas, Cordis. “As the first and only sirolimus drug-eluting balloon approved in the United States, SELUTION SLR™ DEB introduces a groundbreaking therapy for the treatment of coronary ISR. This innovative device will enable physicians to address one of the most complex coronary clinical challenges. The introduction of SELUTION SLR™ DEB reinforces Cordis’ commitment to delivering differentiated technologies that expand treatment possibilities and improve outcomes for patients.”

Designated as a Breakthrough Device, SELUTION SLR™ DEB is supported by results from the SELUTION4ISR trial, a prospective, multicenter, randomized, single-blind, controlled non-inferiority study that evaluated SELUTION SLR™ DEB against standard of care (SOC), including 80% drug-eluting stents, in patients with coronary ISR. The trial enrolled more than 400 patients across 48 sites in the United States, Canada, Brazil, and Europe. At 12 months the study met its primary endpoint of non-inferiority in the target population1. In all randomized patients, target lesion failure rates were 15.2% for SELUTION SLR™ and 13.5% for SOC. These results further strengthen the extensive clinical evidence supporting SELUTION SLR™ DEB, which includes data from more than 5,000 patients worldwide.

In the U.S., nearly 1 million percutaneous coronary interventions (PCIs) are performed annually, with approximately 10% addressing ISR.2 With this approval, Cordis is entering the coronary drug-coated balloon market. Beyond ISR, Cordis is proud to announce the completed enrollment in the SELUTION4DeNovo IDE trial, a 960-patient randomized study evaluating SELUTION SLR™ DEB versus drug-eluting stents for the treatment of de novo lesions in small coronary vessels in support of a future FDA premarket approval application.

“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” said George Adams, MD, Chief Medical Officer, Cordis. “The availability of SELUTION SLR™ DEB in the United States is meaningful for interventional cardiologists because it provides an effective and highly deliverable sirolimus-based treatment option while helping minimize the need for another stent. We are proud to help expand treatment choices in ways that can make a real difference in patient care.”

Cordis is a pioneer in sirolimus-based innovation, introducing the first sirolimus drug-eluting stent in the United States in 2003. Today, SELUTION SLR™ DEB is the first and only sirolimus DEB available in the U.S. market. Commercially available in more than 65 countries and used in the treatment of over 250,000 patients worldwide, SELUTION SLR™ DEB is designed to provide Sustained Limus Release (SLR) for up to 90 days without leaving behind a permanent implant.

To learn more about the SELUTION4ISR clinical study and SELUTION SLR™ DEB, visit Cordis.com.

About Cordis

From the first guidewire to the first drug-eluting stent, Cordis has been at the heart of cardiovascular innovation for nearly 70 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.

1. The primary endpoint was Per Protocol (SELUTION SLR DEB16.2% vs SOC 14.5%).
2. Moussa I.D., Mohananey D., Saucedo J., et al. Trends and outcomes of restenosis after coronary stent implantation in the United States. J Am Coll Cardiol. 2020;76:1521-1531.

Kelly May
Director, Corporate Communications
Cordis
kelly.may@cordis.com

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