Cordis receives FDA approval for first sirolimus drug-coated balloon for coronary in-stent restenosis

The U.S. Food and Drug Administration has approved a new device from Cordis that delivers sirolimus via a drug-coated balloon. This is the first sirolimus-eluting balloon cleared for use in treating coronary in-stent restenosis.

The approval includes a breakthrough designation, highlighting the device’s potential to address a common complication where arteries narrow again after stent placement.

Cordis says the cleared balloon will expand treatment options for interventional cardiologists managing restenosis, though commercial rollout details were not disclosed.