Cordis Selution SLR Drug-Eluting Balloon Approved by FDA for In-Stent Restenosis

September 21, 2026—Cordis announced that the FDA has approved the Selution SLR sirolimus drug-eluting balloon (DEB) for the treatment of coronary in-stent restenosis (ISR).

Cordis stated that the Selution SLR is designed to provide sustained limus release (SLR) for up to 90 days without leaving behind a permanent implant. Selution SLR previously received FDA Breakthrough Device designation.

Physicians in the United States will have immediate access to the Selution SLR, which has been commercially available in more than 65 countries, noted Cordis.

“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” commented George Adams, MD, Chief Medical Officer, Cordis, in the company’s press release. “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.”

According to the company, the Selution SLR DEB is supported by results from the SELUTION4ISR trial, which enrolled more than 400 patients across 48 sites in the United States, Canada, Brazil, and Europe. The prospective, multicenter, randomized, single-blind, controlled noninferiority study evaluated the Selution SLR DEB versus standard of care (SOC), including 80% drug-eluting stents, in patients with coronary ISR.

As summarized in the company’s press release, the study met its primary endpoint of noninferiority in the target population (the primary endpoint per protocol was 16.2% for Selution SLR versus 14.5% for SOC) at 12 months. In all randomized patients, target lesion failure rates were 15.2% for Selution SLR and 13.5% for SOC. These results added to the clinical evidence supporting Selution SLR DEB that includes data from more than 5,000 patients worldwide, stated Cordis. The data from SELUTION4ISR were presented by Donald Cutlip, MD, at the TCT 2025 scientific symposium.

Dr. Cutlip and Roxana Mehran, MD, who are Coprincipal Investigators of the SELUTION4ISR clinical trial, discussed the regulatory milestone in the Cordis press release.

“FDA approval of the Selution SLR DEB gives United States physicians an important new option for treating coronary ISR,” commented Dr. Cutlip. “Supported by randomized evidence from the SELUTION4ISR trial, the Selution SLR sirolimus DEB allows us to treat ISR without necessarily adding another permanent layer of metal.”

Dr. Mehran added, “For patients with ISR, having more evidence-based treatment options matters. The approval of the Selution SLR DEB brings a new approach to United States physicians—one that allows us to deliver sustained sirolimus therapy to the vessel with a DEB.”

Matt Muscari, President of Americas, Cordis, stated in the press release. “FDA approval of the Selution SLR DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care,” “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.”

Additionally, Cordis announced the completion of enrollment in the SELUTION4DeNovo investigational device exemption trial. The 960-patient randomized study is 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. The company announced commencement of the trial in November 2023.