Wire · operational-macro
Cordis SELUTION SLR Wins FDA Approval for Coronary In-Stent Restenosis
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 28 September 2026 · Fusion42 review
Cordis has received FDA approval for SELUTION SLR, the first sirolimus drug-eluting balloon for coronary in-stent restenosis (ISR) in the U.S., offering interventional cardiologists a new drug-coated balloon option alongside Boston Scientific's Agent. The approval enables Cordis to compete in the growing U.S. coronary drug-coated balloon market with demonstrated clinical noninferiority to standard care.
This Wire brief sits within Fusion42's coverage of Medtech, and 3 sources have reported it between 22 Sep 2026 and 28 Sep 2026.
◆ ◆ The Wire takeaway
You can now promote a new sirolimus drug-coated balloon in U.S. cath labs that directly challenges Boston Scientific. Adjust your sales pitch to highlight SELUTION SLR’s clinical data and where it fits against repeat stenting and uncoated balloons.
◆ Coverage
3 sources · first reported 22 Sep 2026 · latest 28 Sep 2026
◆ Related on Wire
◆ Topics