The FDA has approved Cordis' Selution SLR drug-eluting balloon, making it the first and only sirolimus-based drug-coated balloon available in the U.S. for treating coronary in-stent restenosis (ISR). Supported by the SELUTION4ISR trial of over 400 patients, which demonstrated non-inferiority to standard care, this technology delivers therapeutic drug release for up to 90 days without leaving a permanent implant. It enters a market previously led by Boston Scientific's paclitaxel-based Agent DCB.
Selution SLR FDA approval
- ▪The Selution SLR drug-eluting balloon is the first and only sirolimus-based drug-eluting balloon approved in the United States.
- ▪The U.S. Food and Drug Administration approved Cordis' Selution SLR drug-eluting balloon for the treatment of coronary in-stent restenosis.
SELUTION4ISR trial results
- ▪The FDA's approval of the Selution SLR drug-eluting balloon was supported by results from the SELUTION4ISR clinical trial.
- ▪The SELUTION4ISR trial enrolled over 400 patients across 48 sites in the United States, Canada, Brazil, and Europe.
- ▪In the SELUTION4ISR trial, the 12-month target lesion failure rate was 15.2% for Selution SLR compared to 13.5% for the standard of care.
Sirolimus sustained release technology
- ▪Cordis pioneered sirolimus-based cardiovascular innovation by introducing the first sirolimus drug-eluting stent in the United States in 2003.
- ▪The Selution SLR drug-eluting balloon is designed to deliver sustained sirolimus therapy for up to 90 days without leaving a permanent implant.
Coronary ISR treatment market
- ▪Nearly 1 million percutaneous coronary interventions are performed annually in the United States, with approximately 10% addressing in-stent restenosis.
- ▪The Selution SLR drug-eluting balloon is commercially available in more than 65 countries and has been used to treat over 250,000 patients worldwide.
Agent DCB comparison
- ▪Boston Scientific's paclitaxel-coated Agent DCB was the first coronary drug-coated balloon approved by the FDA for treating in-stent restenosis.
- ▪The comparative safety and efficacy of the Selution SLR drug-eluting balloon against Boston Scientific's Agent DCB is currently unknown.
De novo lesion studies
- ▪Cordis completed patient enrollment in the 960-patient SELUTION4DeNovo IDE trial evaluating Selution SLR against drug-eluting stents for small coronary vessels.
- ▪The Selution SLR drug-eluting balloon demonstrated noninferior efficacy for treating de novo lesions in coronary arteries in the SELUTION De Novo trial.
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