A coronary artery that has already needed a stent can narrow again. Treating that narrowing with yet another stent restores flow, but adds another permanent metal layer to a vessel that may require treatment again. A balloon that delivers drug and then leaves no new scaffold is an appealing alternative. Whether it is the better choice depends on the lesion, the preparation, and the evidence.
The FDA approved Cordis's SELUTION SLR sirolimus-eluting balloon for coronary in-stent restenosis on September 18, 2026. Cordis announced the decision on September 21. This is the first sirolimus-coated coronary balloon approved in the US, not the first drug-coated balloon: Boston Scientific's paclitaxel-coated AGENT gained approval in 2024.
