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

• Cordis won FDA clearance for its SELUTION SLR drug-eluting balloon to treat coronary in-stent restenosis in the US.
• Product is the first sirolimus drug-eluting balloon cleared in the US, supporting a push into the coronary drug-coated balloon market.
• SELUTION4ISR trial of more than 400 patients met its 12-month non-inferiority endpoint; target lesion failure was 15.2% versus 13.5% standard care.

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