FDA approves SELUTION SLR, first US sirolimus drug-eluting balloon for in-stent restenosis

Cordis has received FDA approval for the SELUTION SLR sirolimus drug-eluting balloon for coronary in-stent restenosis. It is the first and only sirolimus-based balloon approved in the US, backed by the SELUTION4ISR trial of more than 400 patients across 48 sites.

• SELUTION SLR is the first sirolimus drug-eluting balloon approved in the US
• Approval rests on SELUTION4ISR: 400+ patients at 48 sites
• The device releases sirolimus over about 90 days without a permanent implant
• Cordis completed enrollment of a 960-patient trial for small vessels