FDA Approves Cordis’ Sirolimus-Eluting Balloon

FDA has approved Cordis' Selution SLR drug-eluting balloon for treating coronary in-stent restenosis, making it the first sirolimus-eluting balloon cleared in the US and only the second drug-coated balloon of any kind approved for that indication. The approval, announced September 21, 2026, rests on the SELUTION4ISR trial, which randomized more than 400 patients across the US, Canada, Brazil and Europe and met its primary noninferiority endpoint against standard of care at one year.

What the device does

Selution SLR — the name stands for sustained limus release — is a balloon catheter coated with sirolimus held in a microreservoir carrier, delivering the anti-proliferative drug to the vessel wall for up to 90 days after a single inflation, without leaving a permanent metal implant behind. That distinguishes it from a drug-eluting stent, which treats restenosis by placing another permanent scaffold inside an already-stented vessel — a "stent inside a stent" approach interventional cardiologists have long wanted an alternative to, particularly for patients who may need repeat interventions in the same segment over time.

The trial behind the approval

SELUTION4ISR enrolled more than 400 patients with coronary in-stent restenosis at 48 sites across the US, Canada, Brazil and Europe, randomizing them to Selution SLR or standard of care, which in this trial meant repeat drug-eluting stent placement roughly 80% of the time. At one year, the primary endpoint of target lesion failure occurred in 15.2% of the Selution SLR group versus 13.5% of the standard-of-care group — within the trial's prespecified noninferiority margin, the basis on which FDA approved the device rather than requiring it to demonstrate superiority over stenting.

Second to market, first with sirolimus

Selution SLR is not the first drug-coated balloon FDA has approved for coronary in-stent restenosis. Boston Scientific's Agent, a paclitaxel-coated balloon, won that indication in March 2024 and established the regulatory template — a noninferiority trial against standard of care, measured on target lesion failure at one year — that Cordis' own SELUTION4ISR trial follows. What Selution SLR adds is a different drug: sirolimus rather than paclitaxel, a limus-family compound already familiar to interventionalists from most modern drug-eluting stents. For device planners, the approval is also a data point on how FDA is willing to apply an established DCB approval pathway to a second sponsor's device and a different antiproliferative agent, rather than asking each new entrant to reestablish the indication from first principles.

What comes next

Cordis has already completed enrollment in a separate randomized trial comparing Selution SLR against drug-eluting stents for de novo lesions in small coronary vessels — a distinct and larger indication than in-stent restenosis, since it would put the balloon in competition with stenting as a first-line treatment rather than a retreatment option. The company has said it intends that data to support a future PMA submission. Selution SLR previously held FDA Breakthrough Device Designation, awarded ahead of this approval in recognition of the unmet need the device targets.

Frequently asked questions

What did FDA approve?

Cordis' Selution SLR (sustained limus release) drug-eluting balloon, a Class III combination drug-device product, for treating coronary in-stent restenosis (ISR) in the US. It is the first sirolimus-eluting balloon FDA has approved.

What trial supported the approval?

SELUTION4ISR, which randomized more than 400 patients at 48 sites across the US, Canada, Brazil and Europe to Selution SLR or standard of care (about 80% repeat drug-eluting stents). The device met its primary noninferiority endpoint for target lesion failure at one year: 15.2% for Selution SLR versus 13.5% for standard of care.

How does this compare to existing options?

Selution SLR is only the second drug-coated balloon FDA has approved for coronary in-stent restenosis, after Boston Scientific's paclitaxel-coated Agent balloon, approved for the same indication in March 2024. Selution SLR is the first to use sirolimus rather than paclitaxel, delivering the drug for up to 90 days without leaving a permanent implant.

What is next for the device?

Cordis has completed enrollment in a separate randomized trial comparing Selution SLR to drug-eluting stents for de novo lesions in small coronary vessels, which the company intends to support a future PMA submission expanding the balloon's indication.