Cordis Wins FDA Approval for SELUTION SLR Balloon

Miami Lakes, Florida, U.S., September 21, 2026

SELUTION SLR Targets Coronary In-Stent Restenosis

In-stent restenosis occurs when a previously treated coronary artery becomes narrowed again within or around a previously implanted stent. The condition can require additional intervention and remains a challenge in interventional cardiology. SELUTION SLR is designed to provide sustained release of sirolimus, an antiproliferative drug, directly at the treatment site. According to Cordis, its proprietary technology uses microreservoirs containing sirolimus within a phospholipid coating, allowing the drug to be delivered locally while avoiding placement of another permanent stent. The device is FDA-approved for patients undergoing PCI in coronary arteries measuring 2.25 mm to 4.50 mm in diameter, with lesions up to 26 mm in length, when treating ISR.

The technology is intended to address a clinical situation in which additional stent implantation may not be desirable or feasible. By delivering an antiproliferative medicine through a balloon catheter, the approach is designed to treat the narrowed segment while avoiding an additional permanent metallic implant. Cordis states that the device can provide sustained limus release for up to 90 days, supporting continued local drug exposure after the procedure. The FDA indication specifically covers improving myocardial perfusion when treating coronary ISR following appropriate vessel preparation.

Clinical Data Support FDA Approval

The FDA decision was supported by data from the SELUTION4ISR clinical trial, a prospective, multicenter, randomized, single-blind, controlled non-inferiority study comparing SELUTION SLR with standard of care 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 population. Among all randomized participants, target lesion failure occurred in 15.2% of patients treated with SELUTION SLR and 13.5% of those receiving standard of care, according to Cordis.

The clinical evidence adds to a broader body of experience with the technology. Cordis reports that SELUTION SLR has been used in more than 250,000 patients worldwide and is commercially available in more than 65 countries. The company also said the broader clinical evidence base includes data from more than 5,000 patients. The U.S. approval now expands availability of the technology to American interventional cardiologists for the specific FDA-approved ISR indication.

Cordis Expands Drug-Eluting Balloon Development

The FDA clearance represents Cordis’ entry into the U.S. coronary drug-coated balloon market and forms part of the company’s broader cardiovascular technology strategy. In addition to the ISR indication, Cordis announced completion of enrollment in the SELUTION4DeNovo IDE trial, a randomized study involving 960 patients that is evaluating SELUTION SLR against drug-eluting stents for de novo lesions in small coronary vessels. The company said the study is intended to support a potential future FDA application for that indication.

The approval gives physicians another device-based option for managing coronary in-stent restenosis, particularly in situations where avoiding another permanent stent may be clinically appropriate. While SELUTION SLR combines a drug-delivery technology with an established PCI balloon platform, its use remains subject to the FDA-approved indication, labeling, contraindications, warnings, and physician judgment. The regulatory milestone nevertheless represents an important advancement for drug-eluting balloon technology and interventional cardiovascular care in the United States.

Source: Cordis press release