FDA approved Cordis's Selution SLR drug-eluting balloon on September 21 for coronary in-stent restenosis. It is the first sirolimus drug-eluting balloon approved in the United States. The device had carried Breakthrough Device designation.
The approval rests on SELUTION4ISR, a randomized, single-blind, controlled non-inferiority trial. It enrolled more than 400 patients at 48 sites across the United States, Canada, Brazil and Europe. Target lesion failure at one year hit 16.2 percent in the balloon arm against 14.5 percent in the control arm, inside the non-inferiority margin.
The balloon carries sirolimus in 4 micron biodegradable microreservoirs that release the drug over about 90 days. A phospholipid coating holds the drug on the balloon during delivery. Nothing stays behind in the vessel. Cordis picked up the technology when it bought MedAlliance for $1.135 billion in 2023.
A 1.7 point gap on target lesion failure clears a non-inferiority bar without settling the commercial case. That argument runs on deliverability and on skipping another metal layer in a vessel that already failed once. Cordis has finished enrollment in a trial of small de novo coronary lesions and plans a further submission.