FDA approves Cordis SELUTION SLR drug-eluting balloon for coronary restenosis

Cordis said the FDA cleared its SELUTION SLR drug-eluting balloon to treat coronary in-stent restenosis in the US. The company said it is the first sirolimus drug-eluting balloon cleared in the US. In the SELUTION4ISR trial of more than 400 patients, the 12-month non-inferiority endpoint was met, with target lesion failure at 15.2% versus 13.5% standard care.